Weight Loss Clinical Trial
Official title:
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
NCT number | NCT04006002 |
Other study ID # | 19-0112 |
Secondary ID | |
Status | Terminated |
Phase | |
First received | |
Last updated | |
Start date | July 1, 2019 |
Est. completion date | January 28, 2022 |
Verified date | January 2022 |
Source | Northwell Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Terminated |
Enrollment | 4 |
Est. completion date | January 28, 2022 |
Est. primary completion date | June 30, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: 1. BMI = 30 Kg/m2 scheduled to undergo a bariatric intervention 2. Patients who will be undergoing ESG or LSG as part of their clinical care Age between 18 and 75 years. 3. Both male and female subjects will be included in the study. 4. Subjects from any ethnic background will be included in the study. 5. 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). 6. Successfully complete the screening process. 7. Patients able to provide written informed consent on the IRB/EC-approved informed consent form. 8. Demonstrate willingness to follow protocol requirements, including follow-up schedule, and completion of questionnaires. 9. Having standard of care therapy (endoscopic or laproscopic) for treatment of Obesity. Exclusion Criteria: 1. Pregnant or planning to become pregnant during period of study participation. 2. Female participants who are breast-feeding. 3. Severe Immunodeficiency. 4. Severe malnutrition. 5. The participant has life expectancy of less than 1 year due to other medical conditions. |
Country | Name | City | State |
---|---|---|---|
United States | Northwell Health | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Northwell Health |
United States,
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. — View 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. Review. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of participants with GERD before and after intervention | 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 | 1 years | |
Secondary | Compare gastric emptying after intervention | 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 | 1 year |
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