Ignite Creation Date:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2025-12-31 @ 8:24 AM
Study NCT ID:
NCT02016612
Status:
COMPLETED
Last Update Posted:
2018-02-13
First Post:
2013-12-16
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Seri Surgical Scaffold Support of the Lower Pole of the Breast
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D001763', 'term': 'Blepharoptosis'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005141', 'term': 'Eyelid Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'drb@bengtsoncenter.com', 'phone': '616 588 8880', 'title': 'Dr Bradley Bengtson', 'organization': 'Bengtson Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Reduction, Mastopexy No Implant, No Seri', 'description': 'Patients undergoing reduction or mastopexy but no implant is used and no Seri support\n\nSeri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast.', 'otherNumAtRisk': 25, 'otherNumAffected': 3, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Mastopexy, Implant no Seri Scaffold', 'description': 'Mastopexy with implant, No Seri support is used\n\nSeri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast.', 'otherNumAtRisk': 25, 'otherNumAffected': 2, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Breast Reduction With Seri Support', 'description': 'Patients undergoing breast reduction with the use of Seri support\n\nSeri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast.', 'otherNumAtRisk': 26, 'otherNumAffected': 3, 'seriousNumAtRisk': 26, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'Augmentation Mastopexy, Implant and Seri', 'description': 'Augmentation Mastopexy patients where Seri Scaffold is placed\n\nSeri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast.', 'otherNumAtRisk': 61, 'otherNumAffected': 2, 'seriousNumAtRisk': 61, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'skin dehiscence', 'notes': 'skin dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cellulitis', 'notes': 'Superficial infection limited to the skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'seroma', 'notes': 'seroma and partial Seri removal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'dehiscence', 'notes': 'skin dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 61, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Nipple to Fold Measurement on Stretch', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Reduction, Mastopexy No Implant, No Seri', 'description': 'Patients undergoing reduction or mastopexy but no implant is used and no Seri support\n\nSeri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast.'}, {'id': 'OG001', 'title': 'Mastopexy, Implant no Seri Scaffold', 'description': 'Mastopexy with implant, No Seri support is used\n\nSeri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast.'}, {'id': 'OG002', 'title': 'Breast Reduction With Seri Support', 'description': 'Patients undergoing breast reduction with the use of Seri support\n\nSeri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast.'}, {'id': 'OG003', 'title': 'Augmentation Mastopexy, Implant and Seri', 'description': 'Augmentation Mastopexy patients where Seri Scaffold is placed\n\nSeri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000', 'lowerLimit': '1.2', 'upperLimit': '4.2'}, {'value': '2.5', 'groupId': 'OG001', 'lowerLimit': '1.2', 'upperLimit': '4.1'}, {'value': '1.4', 'groupId': 'OG002', 'lowerLimit': '0.5', 'upperLimit': '2.6'}, {'value': '1.4', 'groupId': 'OG003', 'lowerLimit': '0.7', 'upperLimit': '2.6'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year post op', 'description': 'The Nipple to fold will be measured manually over time to 1 year', 'unitOfMeasure': 'centimeters', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Breast Tissue Above Nipple', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '61', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Reduction, Mastopexy No Implant, No Seri', 'description': 'Patients undergoing reduction or mastopexy but no implant is used and no Seri support\n\nSeri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast.'}, {'id': 'OG001', 'title': 'Mastopexy, Implant no Seri Scaffold', 'description': 'Mastopexy with implant, No Seri support is used\n\nSeri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast.'}, {'id': 'OG002', 'title': 'Breast Reduction With Seri Support', 'description': 'Patients undergoing breast reduction with the use of Seri support\n\nSeri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast.'}, {'id': 'OG003', 'title': 'Augmentation Mastopexy, Implant and Seri', 'description': 'Augmentation Mastopexy patients where Seri Scaffold is placed\n\nSeri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast.'}], 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '100'}, {'value': '30', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '100'}, {'value': '15', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '100'}, {'value': '18', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '100'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year post op', 'description': 'The percentage of breast tissue above and below the horizontal plane of the nipple over time', 'unitOfMeasure': 'percentage of volume', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Reduction, Mastopexy No Implant, No Seri', 'description': 'Patients undergoing reduction or mastopexy but no implant is used and no Seri support\n\nSeri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast.'}, {'id': 'FG001', 'title': 'Mastopexy, Implant no Seri Scaffold', 'description': 'Mastopexy with implant, No Seri support is used\n\nSeri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast.'}, {'id': 'FG002', 'title': 'Breast Reduction With Seri Support', 'description': 'Patients undergoing breast reduction with the use of Seri support\n\nSeri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast.'}, {'id': 'FG003', 'title': 'Augmentation Mastopexy, Implant and Seri', 'description': 'Augmentation Mastopexy patients where Seri Scaffold is placed\n\nSeri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '26'}, {'groupId': 'FG003', 'numSubjects': '61'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '26'}, {'groupId': 'FG003', 'numSubjects': '61'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '61', 'groupId': 'BG003'}, {'value': '137', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Reduction, Mastopexy No Implant, No Seri', 'description': 'Patients undergoing reduction or mastopexy but no implant is used and no Seri support\n\nSeri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast.'}, {'id': 'BG001', 'title': 'Mastopexy, Implant no Seri Scaffold', 'description': 'Mastopexy with implant, No Seri support is used\n\nSeri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast.'}, {'id': 'BG002', 'title': 'Breast Reduction With Seri Support', 'description': 'Patients undergoing breast reduction with the use of Seri support\n\nSeri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast.'}, {'id': 'BG003', 'title': 'Augmentation Mastopexy, Implant and Seri', 'description': 'Augmentation Mastopexy patients where Seri Scaffold is placed\n\nSeri Surgical Scaffold: An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '61', 'groupId': 'BG003'}, {'value': '137', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000', 'lowerLimit': '20', 'upperLimit': '63'}, {'value': '38', 'groupId': 'BG001', 'lowerLimit': '20', 'upperLimit': '56'}, {'value': '48', 'groupId': 'BG002', 'lowerLimit': '39', 'upperLimit': '65'}, {'value': '37', 'groupId': 'BG003', 'lowerLimit': '26', 'upperLimit': '65'}, {'value': '42', 'groupId': 'BG004', 'lowerLimit': '20', 'upperLimit': '65'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '61', 'groupId': 'BG003'}, {'value': '137', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '61', 'groupId': 'BG003'}, {'value': '128', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '61', 'groupId': 'BG003'}, {'value': '137', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2016-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-17', 'studyFirstSubmitDate': '2013-12-16', 'resultsFirstSubmitDate': '2016-11-15', 'studyFirstSubmitQcDate': '2013-12-19', 'lastUpdatePostDateStruct': {'date': '2018-02-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-01-17', 'studyFirstPostDateStruct': {'date': '2013-12-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nipple to Fold Measurement on Stretch', 'timeFrame': '1 year post op', 'description': 'The Nipple to fold will be measured manually over time to 1 year'}], 'secondaryOutcomes': [{'measure': 'Percent Breast Tissue Above Nipple', 'timeFrame': '1 year post op', 'description': 'The percentage of breast tissue above and below the horizontal plane of the nipple over time'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Recurrent', 'Ptosis', 'Reduction', 'Mammoplasty', 'Mastopexy'], 'conditions': ['Recurrent Ptosis of the Breast']}, 'descriptionModule': {'briefSummary': 'Will the use of an FDA approved highly purified silk scaffold; Seri Surgical Scaffold help shape and hold the breast up on the chest preventing re-stretching and bottoming out of the breast in breast reduction or augmentation-mastopexy patients? The amount of stretch will be measured manually as well as percent of breast tissue measured with the Canfield Vectra 3-D Imaging system reporting the amount of breast tissue above and below the nipple level.', 'detailedDescription': 'Patients having augmentation mastopexy or breast reduction will be informed about Seri Scaffold and allowed to have Seri support included in their surgery or not. If the choose the scaffold will be placed under the skin in the lower pole of the breast as an internal hammock to help take weight off of the breast and potentially help prevent future stretch of the lower pole.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAge =\\>18 years\n\n* requesting procedure\n* No active cancer or infection\n\nExclusion Criteria:\n\n* Known allergy to silk\n* Pregnant or lactating'}, 'identificationModule': {'nctId': 'NCT02016612', 'acronym': 'SeriSupport', 'briefTitle': 'Seri Surgical Scaffold Support of the Lower Pole of the Breast', 'organization': {'class': 'OTHER', 'fullName': 'Bengtson Center'}, 'officialTitle': 'Seri Surgical Scaffold (TM) Support of the Lower Pole of the Breasts in Augmentation Mastopexy or Breast Reduction Patients', 'orgStudyIdInfo': {'id': '007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Reduction, Mastopexy No Implant, No Seri', 'description': 'Patients undergoing reduction or mastopexy but no implant is used and no Seri Surgical Scaffold support is used', 'interventionNames': ['Device: Seri Surgical Scaffold']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mastopexy, Implant no Seri Scaffold', 'description': 'Mastopexy with implant, No Seri Surgical Scaffold support is used', 'interventionNames': ['Device: Seri Surgical Scaffold']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Breast Reduction with Seri Support', 'description': 'Patients undergoing breast reduction with the use of Seri Surgical scaffold support', 'interventionNames': ['Device: Seri Surgical Scaffold']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Augmentation Mastopexy, Implant and Seri', 'description': 'Augmentation Mastopexy patients where Seri Surgical scaffold is used', 'interventionNames': ['Device: Seri Surgical Scaffold']}], 'interventions': [{'name': 'Seri Surgical Scaffold', 'type': 'DEVICE', 'otherNames': ['Seri', 'Seri Scaffold'], 'description': 'An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast.', 'armGroupLabels': ['Augmentation Mastopexy, Implant and Seri', 'Breast Reduction with Seri Support', 'Mastopexy, Implant no Seri Scaffold', 'Reduction, Mastopexy No Implant, No Seri']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'Bengtson Center for Aesthetics and Plastic Surgery', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'Center for Aesthetics and Plastic Surgery', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}], 'overallOfficials': [{'name': 'Bradley P Bengtson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bengtson Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bengtson Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Allergan Medical', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Bradley P Bengtson, MD FACS', 'investigatorFullName': 'Bradley Bengtson, M.D.', 'investigatorAffiliation': 'Bengtson Center'}}}}