Status:
RECRUITING
Marginal Ulcer Healing With Low-Thermal Argon Plasma Endoscopic Treatment
Lead Sponsor:
Christopher C. Thompson, MD, MSc
Collaborating Sponsors:
Erbe USA Incorporated
Conditions:
Roux-en-y Anastomosis Site
Marginal Ulcer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 s...
Detailed Description
Gastric bypass surgery, specifically Roux-en-Y gastric bypass (RYGB), is the second most common bariatric procedure performed worldwide (29.3%) after sleeve gastrectomy (55.4%). Despite its success in...
Eligibility Criteria
Inclusion
- 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.
- Willingness to adhere to the SOC treatment, which includes PPIs.
- Subjects able to tolerate repeated endoscopic procedures.
- Capacity for providing informed consent and understanding of study requirements.
- Willingness and ability to attend required follow-up assessments at 4 weeks (+/- 1 week) and 8 weeks (+/- 2 weeks).
Exclusion
- Inability to provide informed consent.
- Unwillingness to undergo repeated endoscopies.
- Inability or unwillingness to comply with the SOC.
- Current use of systemic antibiotics.
- Any condition deemed by the investigator to compromise the safety of undergoing an endoscopic procedure.
- Pregnancy, lactation, or absence of reliable contraception in women of childbearing potential.
- Current enrollment in another investigational trial with potential to interfere with this study's endpoint analyses.
Key Trial Info
Start Date :
March 4 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06543316
Start Date
March 4 2025
End Date
April 30 2027
Last Update
August 5 2025
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115