Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2026-03-06 @ 10:11 PM
Study NCT ID:
NCT01402505
Status:
WITHDRAWN
Last Update Posted:
2020-03-31
First Post:
2011-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transvaginal NOTES Sleeve Gastrectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2018-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-28', 'studyFirstSubmitDate': '2011-07-21', 'studyFirstSubmitQcDate': '2011-07-25', 'lastUpdatePostDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-07-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess outcomes related to the transvaginal NOTES approach to laparoscopic sleeve gastrectomy (through data collection).', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'To assess pain associated with the transvaginal NOTES approach to laparoscopic sleeve gastrectomy (through data collection).', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['obesity', 'sleeve gastrectomy', 'transvaginal NOTES'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'This is a prospective chart review/data collection study of natural orifice translumenal endoscopic surgery (NOTES) for sleeve gastrectomy, that will include questionnaires administered throughout the study. Subjects enrolled will be those intending to have a transvaginal NOTES sleeve gastrectomy. Data will be collected and reviewed through 12 months post-op.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients between the ages of 18-75 who present in the UC San Diego Surgical Specialties clinic and have been cleared by the Bariatric and Metabolic Institute (BMI) team for bariatric surgery will be evaluated for participation in this trial. If the inclusion and exclusion criteria are met, the patients will be offered participation in the trial.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion:\n\n1. Diagnosis of morbid obesity BMI \\> 40\n2. Female, age 18-75\n3. Mentally competent to give informed consent\n4. Scheduled to undergo a transvaginal NOTES sleeve gastrectomy\n\nExclusion:\n\n1. Pregnant women\n2. BMI \\< 40'}, 'identificationModule': {'nctId': 'NCT01402505', 'briefTitle': 'Transvaginal NOTES Sleeve Gastrectomy', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'officialTitle': 'Natural Orifice Translumenal Endoscopic Surgery (NOTES): Laparoscopic Assisted Trans-Vaginal Sleeve Gastrectomy', 'orgStudyIdInfo': {'id': '081036, 141812'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Transvaginal NOTES sleeve gastrectomy', 'description': 'Transvaginal NOTES sleeve gastrectomy', 'interventionNames': ['Procedure: Transvaginal NOTES sleeve gastrectomy']}], 'interventions': [{'name': 'Transvaginal NOTES sleeve gastrectomy', 'type': 'PROCEDURE', 'description': 'transvaginal NOTES sleeve gastrectomy', 'armGroupLabels': ['Transvaginal NOTES sleeve gastrectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}], 'overallOfficials': [{'name': 'Santiago Horgan, M.D., FACS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCSD'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Diego', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Surgery', 'investigatorFullName': 'Santiago Horgan', 'investigatorAffiliation': 'University of California, San Diego'}}}}