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New Ruler-on-a-Stick could help solve weight regain after gastric bypass

NCT ID NCT04832282

Knowledge-focused Sponsor: NYU Langone Health Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests a new device called Napoleon, a tiny catheter with a ruler, to measure the size of the stomach-connection opening in people who have regained weight after gastric bypass surgery. Doctors will compare measurements taken with the device to their usual visual estimates. Up to 100 patients will take part, and the goal is to see if the device is easy to use and gives more consistent results.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Napoleon device (a small catheter with a ruler for measuring)
What this could lead to
If successful, this could give doctors a more accurate way to measure the stomach connection, potentially guiding better treatment for weight regain after gastric bypass.
What could go wrong
This is an early feasibility study with only 100 participants, so results may not apply to everyone. The device is used off-label, and its benefit over simple visual estimation is not yet proven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2021

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 90 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gastric bypass Weight regain

Contacts and locations

Locations

  • Bellevue Hospital Center

    New York, New York, 10016, United States

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

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