Actively Recruiting
Marginal Ulcer Healing With Low-Thermal Argon Plasma Endoscopic Treatment
Led by Christopher C. Thompson, MD, MSc · Updated on 2025-08-05
100
Participants Needed
1
Research Sites
112 weeks
Total Duration
On this page
Sponsors
C
Christopher C. Thompson, MD, MSc
Lead Sponsor
E
Erbe USA Incorporated
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Marginal Ulcer Healing With Low-Thermal Argon Plasma Endoscopic Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects aged 18 years and above, including both males and females
- History of Roux-en-Y gastric bypass surgery with symptoms like abdominal pain, nausea, vomiting, gastrointestinal bleeding, or dysphagia
- Scheduled for an esophagogastroduodenoscopy (EGD) to evaluate symptoms
- Marginal ulcers confirmed during the initial EGD
- Willing to follow standard care treatment including proton pump inhibitors (PPIs)
- Able to tolerate repeated endoscopic procedures
- Capable of giving informed consent and understanding study requirements
- Willing and able to attend follow-up visits at 4 weeks (+/- 1 week) and 8 weeks (+/- 2 weeks)
You will not qualify if you...
- Unable to provide informed consent
- Unwilling to undergo repeated endoscopies
- Unable or unwilling to comply with standard care treatment
- Currently using systemic antibiotics
- Any condition that makes endoscopy unsafe according to the investigator
- Pregnant, breastfeeding, or women of childbearing potential without reliable contraception
- Currently enrolled in another investigational trial that could affect study results
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
M
Michele B Ryan, MS
CONTACT
S
Samantha Geltz
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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