Recruiting

Argon Plasma

Sponsor:

Christopher C. Thompson, MD, MSc

Code:

NCT06543316

Conditions

Roux-en-y Anastomosis Site

Marginal Ulcer

Marginal Ulcer (Peptic) or Erosion

Ulcer

Ulcer, Gastric

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Low Thermal Plasma (LTP) Treatment

Standard of Care Ulcer Treatment (typically PPI Administration)

Study Details

Brief summary:

The objective of the study is to investigate the treatment of marginal ulcers with Low Thermal plasma in an endoscopic setting. By a treatment of the ulcerated areas with argon plasma with low power settings (\~ 1 W) we hypothesize that the size of the ulcers will shrink, and the healing is accelerated compared to standard of care alone. Patients will benefit from this minimally invasive approach compared to a much more invasive surgical approach that comes with higher risks and hospital stay length time. From a societal and scientific perspective, this study aims to extend the well-documented clinical benefits of plasma technology - from external wound healing to internal ulcer treatment - within an endoscopic framework. The success of this study could pave the way for broader applications of LTP in the treatment of other endoscopically accessible conditions such as peptic ulcers, duodenal ulcers and esophageal ulcers. This advancement has the potential not only to improve patient outcomes through less invasive methods, but also to position LTP as a cornerstone in the future of gastroenterological wound management strategies.

Conditions

Roux-en-y Anastomosis Site

Marginal Ulcer

Marginal Ulcer (Peptic) or Erosion

Ulcer

Ulcer, Gastric

Study ID

NCT06543316

Start date

Mar 4, 2025

Status verified date

Jun, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Low Thermal Plasma (LTP)

Patients randomized to this group will receive LTP treatment of the ulcer in addition to SOC (PPI administration).

active comparator: Standard of Care (SOC) PPI Administration

Patients randomized to this group will receive only the SOC treatment (PPI administration).

Interventions

Low Thermal Plasma (LTP) Treatment

For patients randomized to the LTP group, the first LTP treatment will be administered during the initial esophagogastroduodenoscopy (EGD) using a single-use 2.3 mm filtered argon plasma coagulation (FiAPC probe). The argon plasma will be applied at low power settings (\~1 W) to the ulcerated areas using pulsed APC effect 0.1.

Standard of Care Ulcer Treatment (typically PPI Administration)

Standard of care for treatment of ulcers is administration of a proton pump inhibitor (PPI). For patients in the SOC group whose ulcers have not healed completely by the second follow-up at 8 weeks, crossover to LTP treatment will be offered. This treatment will follow the same procedure as the initial LTP treatment.

Primary outcome measure

  • Ulcer Healing Success Rate from baseline endoscopy [ Time Frame: Baseline, 4 weeks, 8 Weeks ]

Central Contacts and Locations

Central contacts

Michele B Ryan, MS

617-525-8266mryan@bwh.harvard.edu

Samantha Geltz

617-732-5174sgeltz@bwh.harvard.edu

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Michele B. Ryan, MS

6175258266mryan@bwh.harvard.edu

Principal Investigator:

Christopher C. Thompson, MD, MSc

More Information

Sponsor

Christopher C. Thompson, MD, MSc

Last update posted

Jun 25, 2026

Last verified

Jun, 2026

Keywords

  • Argon Plasma Coagulation
  • APC
  • Low-Thermal Argon Plasma Endoscopic Treatment
  • Endoscopy
  • RYGB
  • Roux-en-Y Gastric Bypass
  • Ulcer Healing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Christopher C. Thompson, MD, MSc on 2026-06-25.