Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2025-12-24 @ 2:16 PM
Study NCT ID:
NCT02072395
Status:
COMPLETED
Last Update Posted:
2017-02-20
First Post:
2014-02-24
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Gastric Plication and Banding
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-16', 'studyFirstSubmitDate': '2014-02-24', 'studyFirstSubmitQcDate': '2014-02-24', 'lastUpdatePostDateStruct': {'date': '2017-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-02-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight loss', 'timeFrame': 'Two years', 'description': 'The primary endpoint is weight loss two years post-surgery.'}, {'measure': 'Complications', 'timeFrame': '2 years', 'description': 'Intra and post-operative complications will be tracked.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['morbid obesity', 'bariatric surgery', 'gastric banding', 'gastric plication'], 'conditions': ['Morbid Obesity']}, 'referencesModule': {'references': [{'pmid': '25443058', 'type': 'BACKGROUND', 'citation': 'Chaudhry UI, Osayi SN, Suzo AJ, Noria SF, Mikami DJ, Needleman BJ. Laparoscopic adjustable gastric banded plication: case-matched study from a single U.S. center. Surg Obes Relat Dis. 2015 Jan-Feb;11(1):119-24. doi: 10.1016/j.soard.2014.05.030. Epub 2014 Jun 4.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to assess the efficacy of a hybrid laparoscopic surgical procedure for treatment of morbid obesity, Gastric Plication (G)) and Gastric Banding.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 18-70\n* BMI \\> or = to 30 and co-morbid conditions or BMI \\> or = to 40\n* Ability to provide informed consent\n* Willingness to commit to long-term follow-up\n\nExclusion Criteria:\n\n* Inability to provide informed consent\n* Presence of metabolic or medically correctable cause(s) for obesity, such as untreated hypothyroidism or Prader-Willi\n* Contraindications to surgery such as myocardial infarction within last 6 months, end stage renal or liver disease, current infection, or other disease states contraindicative to surgery, in the principal investigator's opinion\n* Pregnancy\n* Plan to become pregnant within two years post-surgery\n* Current addiction to drugs or alcohol\n* Previous history of any type of bariatric surgery (de novo group only)\n* Hiatal hernia \\> 3 cm"}, 'identificationModule': {'nctId': 'NCT02072395', 'acronym': 'GP and Band', 'briefTitle': 'Gastric Plication and Banding', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University'}, 'officialTitle': 'Treatment of Morbid Obesity With Gastric Plication and Gastric Banding', 'orgStudyIdInfo': {'id': '2012H0003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Band/Plication', 'description': 'Treatment -- band/plication', 'interventionNames': ['Procedure: Plication']}], 'interventions': [{'name': 'Plication', 'type': 'PROCEDURE', 'description': 'Plication of the stomach will be performed in conjunction with placement of a gastric band.', 'armGroupLabels': ['Band/Plication']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University Wexner Medical Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Bradley J Needleman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Bradley Needleman', 'investigatorAffiliation': 'Ohio State University'}}}}