Marginal Ulcer Healing With Low-Thermal Argon Plasma Endoscopic Treatment
NCT Number: NCT06543316
Acronym: AMULET
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
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|OTHER: Standard of Care Ulcer Treatment (typically PPI Administration)
Sponsor: Christopher C. Thompson, MD, MSc
Collaborators: Erbe USA Incorporated
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-11-01
Completion Date: 2026-04-30
Locations: Brigham and Women's Hospital, Boston, Massachusetts, 02115, United States

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.

Primary Outcome Measures: Ulcer Healing Success Rate from baseline endoscopy, Complete healing or significant reduction in ulcer size, determined by endoscopic evaluation at the first follow-up (4 weeks +/- 1 week) and at the end of the second follow-up period (8 weeks +/- 2 weeks)., Baseline, 4 weeks, 8 Weeks
Secondary Outcome Measures: Comparison of Time to Ulcer Healing between LTP and SOC groups, To measure the time in days from initial treatment to complete ulcer healing in both treatment phases, accounting for the initial ulcer size., Baseline, 4 weeks, 8 weeks|Improvement of Tissue Oxygenation at Ulcer Site in LTP treatment group, To measure the change of the tissue oxygenation in the ulcerated area directly after the LTP treatment and at the follow-up visits. Level of tissue oxygenation will be compared to a baseline measurement before the initial LTP treatment. Level of tissue oxygenation measured by light absorption with an image sensor (ELUXEO Vision System, Fujifilm)., Baseline, 4 weeks, 8 weeks|Presence of Procedure-Related Adverse Events, To evaluate the safety profile of LTP by recording the presence of adverse events such as bleeding, perforation, and infection in both initial and crossover phases from during the procedure up to 8 weeks post-procedure., Baseline, up to 8 weeks|Clinical Improvement of Gastrointestinal Symptoms, Change in Gastrointestinal Symptoms from Baseline Using the gastrointestinal symptom rating scale (GSRS). This has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms., Baseline, 8 Weeks|Change in quality of life score from baseline using the 12 item Short Form Survey (SF-12), Comparison of quality of life scores from baseline to 4 weeks post-treatment using the SF-12 scoring system. Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning. A score of 50 or less has been recommended as a cut-off to determine a physical condition in the Physical Health Composite Score (PCS) section; while a score of 42 or less may be indicative of 'clinical depression' Mental Health Composite Score (MCS) section., Baseline, 8 Weeks