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NCT Number: NCT04832282

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. 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Gastric Bypass Weight Regain

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital, Boston, Massachusetts, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Napoleon

Device

The Micro-Tech Endoscopic Measurement Device named Napoleon is a small catheter with a 30mm ruler calibrated at 1mm intervals with 5mm demarcations. It is classified as a Class 1, 510(k) exempt device by the FDA. The device was originally intended to measure polyps. However, it is used off-label in this study and is considered investigational.

Visual estimation

Other

For each case, endoscopists will first visually estimate the diameter of the GJA by comparing its size to the upper endoscope.

Primary outcomes

  1. Mean difference in measured Gastrojejunal Anastomosis size between Napoleon and visual estimation

    Time frame: 8 months

Secondary outcomes

  1. Proportion of cases with different recommended endoscopic treatment based on GJA size measured by Napoleon Device

    Time frame: 8 months

  2. Level of ease with using Napoleon in terms of placement, extension/retraction, and photo acquisition

    Time frame: 8 months

  3. Additional procedure time needed to incorporate use of Napoleon

    Time frame: 8 months

  4. Proportion of cases with adverse events or unanticipated problems related to use of Napoleon

    Time frame: 8 months

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • Brigham and Women's Hospital

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Apr 5, 2021
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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