Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:28 AM
Study NCT ID:
NCT00285220
Status:
COMPLETED
Last Update Posted:
2009-02-19
First Post:
2006-01-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Laparoscopic Truncal Vagotomy for the Treatment of Obesity
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-02-17', 'studyFirstSubmitDate': '2006-01-31', 'studyFirstSubmitQcDate': '2006-01-31', 'lastUpdatePostDateStruct': {'date': '2009-02-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Excess Weight Loss'}, {'measure': 'Absolute Weight Loss'}, {'measure': 'Change in BMI'}, {'measure': 'Change in Percent Body Fat (DEXA)'}, {'measure': 'Change in Percent Body Fat (Impedence)'}, {'measure': 'Change in Lipid Panel (chol, triglycerides, LDL, HDL'}, {'measure': 'Urinary pH'}, {'measure': '3 day dietary diary'}, {'measure': 'fasting glucose'}, {'measure': 'OGGT with insulin'}, {'measure': 'OGGT with FFA and gut peptides'}, {'measure': 'gastric emptying'}], 'secondaryOutcomes': [{'measure': 'adverse events'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Morbid Obesity']}, 'descriptionModule': {'briefSummary': 'This two site study will evaluate the safety and effectiveness of laparoscopic truncal vagotomy for the treatment of obesity with baseline study and 18 month post op follow up.', 'detailedDescription': '30 morbidly obese patients evenly enrolled at The University of California San Francisco and at the University of Rochester will be selected for study on a voluntary basis. They will have a BMI of \\>35 with at least one obesity related comorbidity or a BMI between 40 and 45. Subjects will undergo specific tests of vagal function and baseline metabolic evaluation at baseline.\n\nThereafter they will undergo a laparoscopic truncal vagotomy. Over 18 months, post operative tests of adequate vagotomy, weight loss, change in body composition and metabolism will be studied.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male or female age 25-55\n* BMI 35-40 with comorbidity and BMI 40-45 with or without comorbidity\n* Stable weight for the last 3 months\n* willing to use contraceptives\n* motivated to lose weight\n* a personal history of at least one professionally supervised 6 month attempt or more than 2 serious attempts to loose weight\n* fully ambulatory\n\nExclusion Criteria:\n\n* sign of prior major abdominal surgery\n* history of or signs and /or symptoms of gastro-duodenal ulcer disease\n* abnormal vagus nerve testing\n* current use of a list of medication'}, 'identificationModule': {'nctId': 'NCT00285220', 'briefTitle': 'Safety and Efficacy of Laparoscopic Truncal Vagotomy for the Treatment of Obesity', 'organization': {'class': 'OTHER', 'fullName': 'University of Rochester'}, 'officialTitle': 'A Prospective, Multi-Center Study to Evaluate the Safety and Effectiveness of Laparoscopic Truncal Vagotomy for the Treatment of Obesity', 'orgStudyIdInfo': {'id': '00011552'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Laparoscopic Truncal Vagotomy', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California at San Francisco, Dept of Pediatrics', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '14624', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Strong Health Bariatric Center at Highland Hospital', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}], 'overallOfficials': [{'name': 'Robert Lustig, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}, {'name': 'Marco Pattti, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}, {'name': 'Thad Boss, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Rochester'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rochester', 'class': 'OTHER'}, 'collaborators': [{'name': 'EndoVx, Inc.', 'class': 'INDUSTRY'}, {'name': 'University of California, San Francisco', 'class': 'OTHER'}]}}}