Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2026-01-01 @ 6:20 PM
Study NCT ID:
NCT03641469
Status:
COMPLETED
Last Update Posted:
2025-06-12
First Post:
2018-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Green Sun Medical Dynamic Scoliosis Brace
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-04-24', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jarthur@greensunmedical.com', 'phone': '720-202-3621', 'title': 'James A. Arthur', 'organization': 'Green Sun Medical'}, 'certainAgreement': {'otherDetails': 'Agreements are not uniform across the sites. The most restrictive agreement states that the site PI and sponsor agree present results only together with the other clinical study sites unless specific written permission is obtained in advance from Sponsor up to 1 year post-completion. After that, the PI can publish/present independently if Sponsor is given the opportunity to review and comment prior to dissemination.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': '1. Enrollment and data collection was interrupted by COVID (e.g. spirometry testing was suspended)\n2. Of the 11 subjects who did not complete the 30 day visit (\\>75 days of follow-up), 6 were among the first 10 subjects enrolled.The GSM brace underwent design and materials changes during the trial, especially during the evaluation of the first 10 subjects.\n3. One study site shut down before all subjects had finished the protocol, resulting in missing data (n=2)'}}, 'adverseEventsModule': {'timeFrame': 'Up to 1 year', 'description': "Any untoward or unfavorable medical occurrence in a participant, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Teams were asked to continuously surveil for AE's during study visits and phone contacts; all AE's were to be reported using a standard case report form. AE's prior to switch to GSM brace at baseline were not recorded.", 'eventGroups': [{'id': 'EG000', 'title': 'Green Sun Dynamic Brace', 'description': 'Use of the Green Sun Dynamic Brace', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 1, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Pressure point of skin related to device', 'notes': 'Subject reported skin irritation in the left axillary area while wearing the GSM brace. The brace was altered and the irritation was resolved without need for medical intervention. Classified as "mild", "expected", "related" to the device.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'SNOMEDCT_US_2024_09_'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Acceptable GSM In-Brace Correction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Green Sun Dynamic Brace', 'description': 'Patients transitioned from current TLSO to GSM brace'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (TLSO measurement) to GSM brace delivery (GSM measurement) within 60 days', 'description': 'Acceptable GSM in-brace correction was defined as a difference of 10 degrees or less between the TLSO and GSM in-brace Cobb angles.', 'unitOfMeasure': 'Percentage acceptable GSM correction', 'reportingStatus': 'POSTED', 'populationDescription': '24 subjects had x-rays in the TLSO and the GSM taken within a 60-day time frame.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Curve Stability or Progression at 3-month Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Green Sun Dynamic Brace', 'description': 'Patients transitioned from current TLSO to GSM brace'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to ~3 mo Follow-up', 'description': 'Curve stability is defined as progression of 10 degrees or less between the Cobb angle at baseline and at follow-up after GSM wear (Baseline Cobb angle minus follow-up Cobb angle).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '28 patients had baseline out-of-brace x-rays taken within 6 months of enrollment'}, {'type': 'PRIMARY', 'title': 'Unanticipated Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Green Sun Dynamic Brace', 'description': 'Patients transitioned from current TLSO to GSM brace'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 1 year', 'description': 'Unanticipated adverse events associated with the GSM brace and patient characteristics likely to raise safety issues', 'unitOfMeasure': "number of AE's reported", 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Brace-related Quality of Life Scores (Brace Questionnaire)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Green Sun Dynamic Brace', 'description': 'Patients transitioned from current TLSO to GSM brace'}], 'classes': [{'categories': [{'measurements': [{'value': '3.82', 'groupId': 'OG000', 'lowerLimit': '-17.37', 'upperLimit': '21.10'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to Visit 3 (3-4 months post-baseline)', 'description': 'Change in Brace Questionnaire (BrQ) scores from baseline (reflecting experience with TLSO) to follow-up (reflecting experience with GSM brace). Total scores range from 20 to 100, with higher scores suggesting better quality-of-life during bracing. A positive change score suggests increased brace-related QOL related to exposure to the GSM brace.', 'unitOfMeasure': 'Units on the scale', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': '14 subjects with both baseline and follow-up BrQ scores for analysis.'}, {'type': 'SECONDARY', 'title': 'Change in Quality of Life Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Green Sun Dynamic Brace', 'description': 'Patients transitioned from current TLSO to GSM brace'}], 'classes': [{'categories': [{'measurements': [{'value': '5.36', 'groupId': 'OG000', 'lowerLimit': '-19.02', 'upperLimit': '18.55'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to Visit 3 (3-4 months post-baseline)', 'description': 'Change in scores on the Italian Spine Youth Quality of Life (ISYQOL) measure from baseline (reflecting experience with TLSO) to follow-up (reflecting experience with GSM brace). The total scores range from 0 to 100% where 100% indicates no problems related to spine or bracing issues. A positive change score suggests increased QOL related to exposure to the GSM brace.', 'unitOfMeasure': 'change in percentage QOL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': '12 subjects had baseline and follow-up ISYQOL scores for analysis'}, {'type': 'SECONDARY', 'title': 'Difference in Vital Capacity Measured in TLSO and GSM Brace', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Green Sun Dynamic Brace', 'description': 'Measurements taken in the TLSO and the GSM brace.'}], 'classes': [{'categories': [{'measurements': [{'value': '82.81', 'spread': '470.80', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Lung vital capacity measured in the TLSO and in the GSM brace to estimate chest wall movement difference. Positive difference favors GSM.', 'unitOfMeasure': 'milliliters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants tested prior to March 2020, after which spirometry testing was stopped due to COVID'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Green Sun Dynamic Brace', 'description': 'TLSO at Baseline followed by GSM brace for 3 months'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Ineligible', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'recruitmentDetails': '36 patients with AIS were enrolled at 6 centers across the US. Recruitment opened May 2018 and continued until January 2024. Enrollment and study procedures were interrupted for several months by COVID in 2020.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Green Sun Dynamic Brace', 'description': 'Eligible subjects treated with a TLSO at baseline'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '34', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '34', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Out-of-brace Cobb angle at Baseline', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '30.68', 'spread': '9.16', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'degrees', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Baseline Cobb angle measurements (from x-ray taken within 180 days prior to baseline) not available for 6 subjects'}], 'populationDescription': 'Excluding 2 enrolled but ineligible subjects'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-01-12', 'size': 717223, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-03-25T12:29', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'The outcomes assessor will be blinded to brace type when measuring the out-of-brace x-ray.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Current TLSO users will crossover to use of the GSM brace.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-05-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-28', 'studyFirstSubmitDate': '2018-05-31', 'resultsFirstSubmitDate': '2025-04-08', 'studyFirstSubmitQcDate': '2018-08-21', 'lastUpdatePostDateStruct': {'date': '2025-06-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-28', 'studyFirstPostDateStruct': {'date': '2018-08-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Acceptable GSM In-Brace Correction', 'timeFrame': 'Baseline (TLSO measurement) to GSM brace delivery (GSM measurement) within 60 days', 'description': 'Acceptable GSM in-brace correction was defined as a difference of 10 degrees or less between the TLSO and GSM in-brace Cobb angles.'}, {'measure': 'Percentage of Participants With Curve Stability or Progression at 3-month Follow-up', 'timeFrame': 'Baseline to ~3 mo Follow-up', 'description': 'Curve stability is defined as progression of 10 degrees or less between the Cobb angle at baseline and at follow-up after GSM wear (Baseline Cobb angle minus follow-up Cobb angle).'}, {'measure': 'Unanticipated Adverse Events', 'timeFrame': 'Up to 1 year', 'description': 'Unanticipated adverse events associated with the GSM brace and patient characteristics likely to raise safety issues'}], 'secondaryOutcomes': [{'measure': 'Change in Brace-related Quality of Life Scores (Brace Questionnaire)', 'timeFrame': 'Baseline to Visit 3 (3-4 months post-baseline)', 'description': 'Change in Brace Questionnaire (BrQ) scores from baseline (reflecting experience with TLSO) to follow-up (reflecting experience with GSM brace). Total scores range from 20 to 100, with higher scores suggesting better quality-of-life during bracing. A positive change score suggests increased brace-related QOL related to exposure to the GSM brace.'}, {'measure': 'Change in Quality of Life Scores', 'timeFrame': 'Baseline to Visit 3 (3-4 months post-baseline)', 'description': 'Change in scores on the Italian Spine Youth Quality of Life (ISYQOL) measure from baseline (reflecting experience with TLSO) to follow-up (reflecting experience with GSM brace). The total scores range from 0 to 100% where 100% indicates no problems related to spine or bracing issues. A positive change score suggests increased QOL related to exposure to the GSM brace.'}, {'measure': 'Difference in Vital Capacity Measured in TLSO and GSM Brace', 'timeFrame': 'Baseline', 'description': 'Lung vital capacity measured in the TLSO and in the GSM brace to estimate chest wall movement difference. Positive difference favors GSM.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Adolescent Idiopathic Scoliosis', 'thoracolumbosacral orthosis', 'spinal orthotic', 'health-related quality of life', 'treatment adherence'], 'conditions': ['Adolescent Idiopathic Scoliosis']}, 'descriptionModule': {'briefSummary': 'This is a pilot study to collect preliminary short-term data concerning the safety and performance of the Green Sun Dynamic brace in a sample of subjects with adolescent idiopathic scoliosis who are currently being treated with a TLSO.', 'detailedDescription': "The Green Sun Medical Dynamic Brace (GSM) brace was developed as an alternative to rigid thoracolumbosacral orthoses (TLSOs, braces) commonly used to prevent continued curve progression in patients with adolescent idiopathic scoliosis (AIS). The brace applies corrective forces to the muscular and bony structures of the spine while preserving range of motion (ROM). The orthosis is prefabricated and adjusted for each patient. A series of semi-rigid segments encircle the patient's torso in close contact and are joined by a structure of flexible elements. These flexible (or elastic) elements generate stabilizing forces, providing the necessary immobilization while allowing relative motion of the semi-rigid segments. To date, this brace has been tested in the lab on healthy volunteers.\n\nThis study will recruit patients currently using a TLSO and compare the curve correction achieved in the GSM brace to that in their current brace. After 3 months in the GSM brace, the out-of-brace Cobb angle will be measured and compared to that at enrollment. Safety will be continually assessed. Brace-related quality of life (comfort, stress, interference with activities) will be self-reported. Adherence to the brace prescription will be measured using an in-brace temperature monitor."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Diagnosis of AIS\n2. Current treatment with a TLSO, of ≥5 months' duration\n3. Existing 3D surface scan of torso and out-of-brace x-ray within the past 6 months\n4. One curve apex below T7\n5. Ability to read and write English\n6. Age 10-15 years\n7. Female sex\n\nExclusion Criteria:\n\n1\\) Parents/patients who decline participation and/or do not sign the consent/assent documents 2) Pregnant women 3) Unwilling or unable to return for follow-up visits\n\n\\-"}, 'identificationModule': {'nctId': 'NCT03641469', 'acronym': 'GSM', 'briefTitle': 'Green Sun Medical Dynamic Scoliosis Brace', 'organization': {'class': 'INDUSTRY', 'fullName': 'Green Sun medical'}, 'officialTitle': 'Green Sun Medical Dynamic Scoliosis Brace', 'orgStudyIdInfo': {'id': '2.0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Green Sun Dynamic Brace', 'description': 'Historical measures of brace effectiveness (in- and out-of-brace Cobb angles), wear time, and brace-related quality of life will be compared to those measured after the subject is fit with a Green Sun dynamic brace.', 'interventionNames': ['Device: Green Sun Dynamic Brace']}], 'interventions': [{'name': 'Green Sun Dynamic Brace', 'type': 'DEVICE', 'description': 'Change from standard-of-care TLSO to GSM brace', 'armGroupLabels': ['Green Sun Dynamic Brace']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital of Los Angeles", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '91105', 'city': 'Pasadena', 'state': 'California', 'country': 'United States', 'facility': "Shriners Children's Southern California", 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Shriners Hospitals for Children - Northern California', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "Children's Healthcare of Atlanta", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '64108', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "Children's Mercy Kansas City", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': "Shriners Children's St. Louis", 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '22031', 'city': 'Fairfax', 'state': 'Virginia', 'country': 'United States', 'facility': 'National Scoliosis Center', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}], 'overallOfficials': [{'name': 'Jamie Haggard', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Green Sun medical'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Green Sun medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}