Measuring the connection in gastric bypass patients
Feasibility of a New Method Named Napoleon to Measure Gastrojejunal Anastomosis in Gastric Bypass Patients With Weight Regain
This study is testing a new device to see if it can more accurately measure a specific part of the stomach in gastric bypass patients who have gained weight back.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | NYU Langone Health Academic / other |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Trial ID | NCT04832282 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the feasibility of the Napoleon device for measuring the gastrojejunal anastomosis (GJA) in Roux-en-Y gastric bypass patients who have experienced weight regain. Participants will undergo endoscopy, during which endoscopists will visually estimate the GJA diameter and then measure it using the Napoleon device. The study aims to compare the accuracy of these two measurement methods and gather feedback from endoscopists regarding the ease of using the Napoleon device. The trial will involve up to 100 cases at two major hospitals.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-90 who have undergone Roux-en-Y gastric bypass and are experiencing weight regain, and are scheduled for an endoscopy.
Not a fit: Patients with a history of prior endoscopies that resulted in complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of measuring GJA, potentially leading to better management of weight regain in gastric bypass patients.
How similar studies have performed: While this approach is novel in the context of measuring GJA, similar studies assessing measurement devices in endoscopic procedures have shown promise.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. RYGB patient with weight regain age 18-90 2. Scheduled for an endoscopy 3. Willingness and ability to provide informed consent Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this study: 1. History of prior endoscopies with complications
Where this trial is running
Boston, Massachusetts and 1 other locations
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
- Bellevue Hospital Center — New York, New York, United States (Recruiting)
Study contacts
- Study coordinator: Violeta Popov, MD
- Email: Violeta.Popov@nyulangone.org
- Phone: 212-686-7500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.