Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06543316

Accelerated Marginal Ulcer Healing With Low-Thermal Argon Plasma Endoscopic Treatment

Led by Christopher C. Thompson, MD, MSc · Updated on 2025-08-05

100

Participants Needed

1

Research Sites

64 weeks

Total Duration

On this page

Sponsors

C

Christopher C. Thompson, MD, MSc

Lead Sponsor

E

Erbe USA Incorporated

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating the treatment of marginal ulcers, which are internal wounds that can occur after Roux-en-Y gastric bypass surgery. This study evaluates the use of low thermal plasma (LTP) applied endoscopically to ulcerated areas. The aim is to see if LTP, applied with low power argon plasma, can reduce ulcer size and speed healing compared to standard care alone. This approach may offer a less invasive alternative to surgery and expand plasma technology use for internal ulcer treatment. Participants will be randomly assigned to one of two groups: one receiving LTP treatment plus standard care with proton pump inhibitors (PPIs), and the other receiving only standard care with PPIs. The LTP treatment is given during an initial endoscopy using a filtered argon plasma probe set to low power settings (~1 W). Patients in the standard care group who do not heal by 8 weeks may crossover to receive LTP treatment. During the study, participants will undergo assessments at baseline, 4 weeks, and 8 weeks, including endoscopic exams to measure ulcer healing. Researchers will monitor tissue oxygenation, gastrointestinal symptoms, quality of life, and any procedure-related adverse events. The main outcome is the rate of ulcer healing by 8 weeks. Participants must attend follow-up visits within specified time windows to evaluate treatment progress and safety.

CONDITIONS

Brief Title

Marginal Ulcer Healing With Low-Thermal Argon Plasma Endoscopic Treatment

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Subjects aged 18 years and above, inclusive of both males and females.
  • Patients with a history of Roux-en-Y gastric bypass presenting symptoms indicative of marginal ulcers such as abdominal pain, nausea, vomiting, gastrointestinal bleeding, or dysphagia.
  • Subjects scheduled for an esophagogastroduodenoscopy (EGD) for symptom evaluation.
  • Marginal ulcers confirmed during the initial EGD.
  • Willingness to follow standard care treatment including proton pump inhibitors.
  • Ability to tolerate repeated endoscopic procedures.
  • Capacity to provide informed consent and understand study requirements.
  • Willingness and ability to attend follow-up visits at 4 weeks (+/- 1 week) and 8 weeks (+/- 2 weeks).
Not Eligible

You will not qualify if you...

  • Inability to provide informed consent.
  • Unwillingness to undergo repeated endoscopies.
  • Inability or unwillingness to comply with standard care.
  • Current use of systemic antibiotics.
  • Any condition considered unsafe for endoscopic procedures by the investigator.
  • Pregnancy, breastfeeding, or lack of reliable contraception in women of childbearing potential.
  • Current participation in another investigational trial that may affect this study's results.

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for initial esophagogastroduodenoscopy (EGD) and ulcer confirmation

Treatment

Duration - Up to 8 weeks

Participants receive either low-thermal argon plasma (LTP) treatment during an endoscopic procedure or standard of care treatment with proton pump inhibitors (PPI). Those in the standard care group who do not heal by 8 weeks may crossover to LTP treatment.

1 initial treatment visit (in-person) plus follow-up visits at 4 weeks and 8 weeks

Trial Site Locations

Total: 1 location

1

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

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Research Team

M

Michele B Ryan, MS

S

Samantha Geltz

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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Frequently Asked Questions

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Published Research Related To This Trial

Development of ulcer disease after Roux-en-Y gastric bypass, incidence, risk factors, and patient presentation: a systematic review.

Usha K Coblijn, Amin B Goucham, Sjoerd M Lagarde...

https://pubmed.ncbi.nlm.nih.gov/24234733

The Healing Effect of Low-Temperature Atmospheric-Pressure Plasma in Pressure Ulcer: A Randomized Controlled Trial.

Apirag Chuangsuwanich, Tananchai Assadamongkol, Dheerawan Boonyawan

https://pubmed.ncbi.nlm.nih.gov/27581113

The feasibility of cold atmospheric plasma in the treatment of complicated wounds in cranio-maxillo-facial surgery.

Stefan Hartwig, Saskia Preissner, Jan Oliver Voss...

https://pubmed.ncbi.nlm.nih.gov/28843407

A first prospective randomized controlled trial to decrease bacterial load using cold atmospheric argon plasma on chronic wounds in patients.

G Isbary, G Morfill, H U Schmidt...

https://pubmed.ncbi.nlm.nih.gov/20222930

Cold Plasma Therapy in Chronic Wounds-A Multicenter, Randomized Controlled Clinical Trial (Plasma on Chronic Wounds for Epidermal Regeneration Study): Preliminary Results.

Nessr Abu Rached, Susanne Kley, Martin Storck...

https://pubmed.ncbi.nlm.nih.gov/37568525