Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:56 AM
Study NCT ID:
NCT04006002
Status:
TERMINATED
Last Update Posted:
2022-02-14
First Post:
2019-06-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mechanism of Weight Loss After Endoscopic and Laparoscopic Sleeve Procedures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015431', 'term': 'Weight Loss'}, {'id': 'D005764', 'term': 'Gastroesophageal Reflux'}], 'ancestors': [{'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D053858', 'term': 'Metabolic Networks and Pathways'}], 'ancestors': [{'id': 'D008660', 'term': 'Metabolism'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'whyStopped': 'Not able to recruit enough patients', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2022-01-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-28', 'studyFirstSubmitDate': '2019-06-07', 'studyFirstSubmitQcDate': '2019-07-01', 'lastUpdatePostDateStruct': {'date': '2022-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of participants with GERD before and after intervention', 'timeFrame': '1 years', 'description': 'Percentage of participants with GERD (\\>6% abnormal esophageal acid exposure calculated via BRAVO pH monitoring for 96 hrs ) before and at 12 months after an endoscopic or surgical bariatric intervention'}], 'secondaryOutcomes': [{'measure': 'Compare gastric emptying after intervention', 'timeFrame': '1 year', 'description': 'To compare gastric emptying and small bowel transit times, before and at 12 months after an endoscopic or surgical bariatric intervention using wireless capsule technology'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Weight Loss', 'Reflux']}, 'referencesModule': {'references': [{'pmid': '27989851', 'type': 'BACKGROUND', 'citation': 'Jirapinyo P, Thompson CC. Endoscopic Bariatric and Metabolic Therapies: Surgical Analogues and Mechanisms of Action. Clin Gastroenterol Hepatol. 2017 May;15(5):619-630. doi: 10.1016/j.cgh.2016.10.021. Epub 2016 Oct 28.'}, {'pmid': '29110192', 'type': 'BACKGROUND', 'citation': 'Novikov AA, Afaneh C, Saumoy M, Parra V, Shukla A, Dakin GF, Pomp A, Dawod E, Shah S, Aronne LJ, Sharaiha RZ. Endoscopic Sleeve Gastroplasty, Laparoscopic Sleeve Gastrectomy, and Laparoscopic Band for Weight Loss: How Do They Compare? J Gastrointest Surg. 2018 Feb;22(2):267-273. doi: 10.1007/s11605-017-3615-7. Epub 2017 Nov 6.'}, {'pmid': '18355825', 'type': 'BACKGROUND', 'citation': 'Fogel R, De Fogel J, Bonilla Y, De La Fuente R. Clinical experience of transoral suturing for an endoluminal vertical gastroplasty: 1-year follow-up in 64 patients. Gastrointest Endosc. 2008 Jul;68(1):51-8. doi: 10.1016/j.gie.2007.10.061. Epub 2008 Mar 19.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to understand the mechanism of weight loss for weight loss procedures: that is Laparoscopic sleeve gastrectomy and Endoscopic sleeve Gastroplasty.', 'detailedDescription': 'We want to better understand the mechanisms for weight loss by understanding the anatomic and physiologic changes that occur with gastric restrictive procedures for weight loss and to determine the differences in metabolic profile between the two restrictive procedures. We also want to identify the rate of Gastro Esophageal Reflux Disease (GERD) in patients undergoing gastric restrictive procedures for weight loss.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Only participants who meet all eligibility criteria will be enrolled in the study. Participants who meet all eligibility criteria and have successfully completed the screening requirements will be asked to sign a Study Consent.\n\nPatients undergoing endoscopic or laparoscopic weight loss procedures will be included.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. BMI ≥ 30 Kg/m2 scheduled to undergo a bariatric intervention\n2. Patients who will be undergoing ESG or LSG as part of their clinical care Age between 18 and 75 years.\n3. Both male and female subjects will be included in the study.\n4. Subjects from any ethnic background will be included in the study.\n5. Female participants of childbearing age should not be pregnant. (Pregnancy test will be performed on all women of child bearing potential before any standard of care endoscopic procedure. For the purpose of the study we will record that information in the patient study records).\n6. Successfully complete the screening process.\n7. Patients able to provide written informed consent on the IRB/EC-approved informed consent form.\n8. Demonstrate willingness to follow protocol requirements, including follow-up schedule, and completion of questionnaires.\n9. Having standard of care therapy (endoscopic or laproscopic) for treatment of Obesity.\n\nExclusion Criteria:\n\n1. Pregnant or planning to become pregnant during period of study participation.\n2. Female participants who are breast-feeding.\n3. Severe Immunodeficiency.\n4. Severe malnutrition.\n5. The participant has life expectancy of less than 1 year due to other medical conditions.'}, 'identificationModule': {'nctId': 'NCT04006002', 'briefTitle': 'Mechanism of Weight Loss After Endoscopic and Laparoscopic Sleeve Procedures', 'organization': {'class': 'OTHER', 'fullName': 'Northwell Health'}, 'officialTitle': 'A Pilot Study to Compare Anatomic, Physiologic, Metabolic and Weight Changes After Standard of Care Endoscopic Gastric Restrictive Bariatric Interventions vs. Standard of Care Laparoscopic Sleeve Gastrectomy', 'orgStudyIdInfo': {'id': '19-0112'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Endoscopic Sleeve Gastrectomy', 'description': 'This group includes all patient who undergo Endoscopic Sleeve Gastrectomy for weight loss', 'interventionNames': ['Other: Metabolic and Hormonal profile']}, {'label': 'Laproscopic Sleeve Gastrectomy', 'description': 'This group includes all patient who undergo Laproscopic Sleeve Gastrectomy for weight loss', 'interventionNames': ['Other: Metabolic and Hormonal profile']}], 'interventions': [{'name': 'Metabolic and Hormonal profile', 'type': 'OTHER', 'description': 'To assess changes in metabolic profiles and body metrics such as weight and BMI in these patients after an endoscopic or surgical bariatric intervention', 'armGroupLabels': ['Endoscopic Sleeve Gastrectomy', 'Laproscopic Sleeve Gastrectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10014', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Northwell Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Petros Benias, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwell Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwell Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}