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.
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.
Inability to provide informed consent.
Unwillingness to undergo repeated endoscopies.
Inability or unwillingness to comply with the SOC.
Current use of systemic antibiotics.
Crossover
Low Thermal Plasma (LTP) Treatment
Procedure/SurgeryFor 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)
Other interventionStandard 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.
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).
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.
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).
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.
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.
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Christopher C. Thompson, MD, MSc
Lead sponsor
Brigham and Women's Hospital
Sponsor institution
Erbe USA Incorporated
Collaborator
