Marginal Ulcer Healing With Low-Thermal Argon Plasma Endoscopic Treatment

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
• Ulcer Gastrointestinal
• Abdominal Pain
• Nausea
• Vomiting
• GastroIntestinal Bleeding
• Dysphagia
• Ulcer 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.

Sponsors & Collaborators

• Erbe USA Incorporated

  collaborator OTHER

• Christopher C. Thompson, MD, MSc

  lead OTHER

Principal Investigators

• Christopher C. Thompson, MD, MSc · Brigham and Womens Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-03-04

Primary Completion

2026-02-28

Completion

2027-04-30

Countries

• United States

Study Locations