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Napoleon Measurement of Gastrojejunal Anastomosis

Recruiting
18 - 90 years of age
Both
Phase N/A

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Overview

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

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

Study details

Gastric Bypass, Weight Regain

NCT04832282

NYU Langone Health

12 January 2025

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Learn more about clinical trials

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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