Marginal Ulcer Healing With Low-Thermal Argon Plasma Endoscopic Treatment

NARecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

March 4, 2025

Primary Completion Date

February 28, 2026

Study Completion Date

April 30, 2027

Conditions
Roux-en-y Anastomosis SiteMarginal UlcerMarginal Ulcer (Peptic) or ErosionUlcerUlcer, GastricUlcer GastrointestinalAbdominal PainNauseaVomitingGastroIntestinal BleedingDysphagiaUlcer Gastrojejunal
Interventions
PROCEDURE

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.

OTHER

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.

Trial Locations (1)

02115

RECRUITING

Brigham and Women's Hospital, Boston

All Listed Sponsors
collaborator

Erbe USA Incorporated

OTHER

lead

Christopher C. Thompson, MD, MSc

OTHER