Feasibility of a New Method Named Napoleon to Measure Gastrojejunal Anastomosis in Gastric Bypass Patients With Weight Regain

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY

This is a clinical trial assessing the feasibility of the Napoleon device for measuring the gastrojejunal anastomosis (GJA). The study population is Roux-en-Y gastric bypass (RYGB) patients with weight regain undergoing an endoscopy at Bellevue Hospital Center or Brigham and Women's Hospital. investigators aim for a sample size of up to 100 cases. For each case, endoscopists will first visually estimate the diameter of the GJA by comparing its size to the upper endoscope. Then, they will measure the GJA with Napoleon. Investigators will compare the GJA measurements performed using visual estimation and Napoleon. A survey will be given to all endoscopists to assess the level of ease using Napoleon.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

⁃ In order to be eligible to participate in this study, an individual must meet all of the following criteria:

• RYGB patient with weight regain age 18-90

• Scheduled for an endoscopy

• Willingness and ability to provide informed consent

Locations
United States
Massachusetts
Brigham and Women's Hospital
RECRUITING
Boston
New York
Bellevue Hospital Center
RECRUITING
New York
Contact Information
Primary
Violeta Popov, MD
Violeta.Popov@nyulangone.org
212-686-7500
Backup
Sandy Ng, MD
Sandy.Ng@nyulangone.org
Time Frame
Start Date: 2021-06-14
Estimated Completion Date: 2025-06-30
Participants
Target number of participants: 100
Treatments
Other: Roux-en-Y gastric bypass patients with weight regain
The study population is Roux-en-Y gastric bypass (RYGB) patients with weight regain undergoing an endoscopy at Bellevue Hospital Center or Brigham and Women's Hospital.
Related Therapeutic Areas
Sponsors
Leads: NYU Langone Health
Collaborators: Brigham and Women's Hospital

This content was sourced from clinicaltrials.gov