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NCT04832282 · ClinicalTrials.gov registry record · NA
Napoleon Measurement of Gastrojejunal Anastomosis
A NA study of Gastric Bypass and Weight Regain, sponsored by NYU Langone Health.
- Active
- Registry status
- NA
- Development phase
- 100
- Enrollment target
- 2
- Study locations
NCT04832282: Active NA study of Gastric Bypass and Weight Regain, sponsored by NYU Langone Health.
NCT04832282 is a NA study of Gastric Bypass and Weight Regain that is active but no longer recruiting, run by NYU Langone Health. The registered enrollment target is 100 participants, above the 78-participant average among 4 other Gastric Bypass trials with a reported enrollment target (28% higher). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04832282, a NA study of Gastric Bypass and Weight Regain, is active but no longer recruiting, sponsored by NYU Langone Health.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
- 2
- Study locations
Study 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.
Conditions Studied
Interventions
- DEVICE Napoleon
- OTHER Visual estimation
Study Locations (2)
Massachusetts
- Brigham and Women's Hospital - Boston
New York
- Bellevue Hospital Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2021-06-14 |
| Est. Completion | 2026-06-30 |
| Phase | NA |
What the registry record for NCT04832282 still lists
NCT04832282 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, above the 78-participant average among 4 other Gastric Bypass trials with a reported enrollment target (28% higher).
The record links to 2 conditions, with Gastric Bypass appearing as the primary indexed condition, and to 2 interventions - of which Napoleon is the first listed.
NCT04832282 reports a single indexed study location in Massachusetts, New York.
Frequently Asked Questions
What is clinical trial NCT04832282 about?
NCT04832282 is a clinical study titled "Napoleon Measurement of Gastrojejunal Anastomosis". 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. invest...
What is the current status of trial NCT04832282?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2021-06-14. Estimated completion is 2026-06-30.
What conditions does trial NCT04832282 study?
This clinical trial studies the following conditions: Gastric Bypass, Weight Regain.
What interventions are being tested in trial NCT04832282?
The interventions under investigation include: Napoleon (DEVICE), Visual estimation (OTHER).
Who is sponsoring clinical trial NCT04832282?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04832282 being conducted?
This trial has 2 study locations across Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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