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Napoleon Measurement of Gastrojejunal Anastomosis
NCT04832282 · View on ClinicalTrials.gov ↗
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04832282
The ClinicalTrials.gov registry entry for NCT04832282 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is NYU Langone Health, which has 1,204 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04832282 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Massachusetts, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04832282?
The interventions under investigation include: Napoleon (DEVICE), Visual estimation (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04832282?
This trial is sponsored by NYU Langone Health, which has 1,204 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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