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Plasma power: new endoscopic treatment could heal Post-Bypass ulcers faster

NCT ID NCT06543316

Disease control Sponsor: Christopher C. Thompson, MD, MSc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new way to treat marginal ulcers that can form after gastric bypass surgery. Instead of just taking standard acid-reducing medication, some participants will also receive a low-thermal argon plasma treatment during an endoscopy. The goal is to see if this plasma treatment helps ulcers heal faster and more completely. The trial will involve 100 adults with confirmed marginal ulcers.

What this could mean

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

Active substance
Low-thermal argon plasma (applied via endoscopy)
What this could lead to
If it works, this could offer a less invasive way to heal marginal ulcers after gastric bypass, reducing the need for surgery.
What could go wrong
This is an early-stage study with only 100 participants, so results may not apply to everyone. The treatment is new for internal ulcers, and its safety and effectiveness are 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

Mar 2025

Expected to finish

Jun 2028

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 years and older

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: * Subjects aged 18 years and above, inclusive of both males and females. * Patients with a history of Roux-en-Y gastric bypass (RYGB) presenting symptoms indicative of marginal ulcers (MUs) such as abdominal pain, nausea, vomiting, gastrointestinal bleeding, or dysphagia. * Subjects must be scheduled for an EGD for the evaluation of these symptoms. * Marginal ulcers confirmed during the initial EGD. * Willingness to adhere to the SOC treatment, which includes PPIs. * Subjects able to tolerate repeated endoscopic procedures. * Capacity for providing informed consent and understanding of study requirements. * Willingness and ability to attend required follow-up assessments at 4 weeks (+/- 1 week) and 8 weeks (+/- 2 weeks). Exclusion Criteria: * Inability to provide informed consent. * Unwillingness to undergo repeated endoscopies. * Inability or unwillingness to comply with the SOC. * Current use of systemic antibiotics. * Any condition deemed by the investigator to compromise the safety of undergoing an endoscopic procedure. * Pregnancy, lactation, or absence of reliable contraception in women of childbearing potential. * Current enrollment in another investigational trial with potential to interfere with this study's endpoint analyses.

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Conditions

The condition(s) this trial relates to.

Abdominal Pain Deglutition Disorders gastric ulcer Gastrointestinal Hemorrhage gastrojejunal ulcer Nausea peptic ulcer disease ulcer disease Vomiting

As listed by the trial registrant

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

Abdominal pain Dysphagia Gastrointestinal bleeding Marginal ulcer Marginal ulcer (peptic) or erosion Nausea Roux-en-Y anastomosis site Ulcer Ulcer gastrointestinal Ulcer gastrojejunal Ulcer, gastric Vomiting

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Brigham and Women's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

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