Napoleon Measurement of Gastrojejunal Anastomosis

  • STATUS
    Recruiting
  • End date
    Jul 1, 2023
  • participants needed
    100
  • sponsor
    NYU Langone Health
Updated on 28 May 2022

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.

Details
Condition Gastric Bypass, Weight Regain
Treatment Napoleon, Visual estimation
Clinical Study IdentifierNCT04832282
SponsorNYU Langone Health
Last Modified on28 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

An individual who meets any of the following criteria will be excluded from participation
in this study
History of prior endoscopies with complications
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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