Marginal Ulcer Healing With Low-Thermal Argon Plasma Endoscopic Treatment

Launched by CHRISTOPHER C. THOMPSON, MD, MSC · Aug 6, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for people with marginal ulcers, which are sores that can develop after certain types of stomach surgeries like the Roux-en-Y gastric bypass. The researchers want to see if using a special technique called Low Thermal Argon Plasma during an endoscopy (a procedure where a thin tube with a camera is inserted to look inside the body) can help these ulcers heal faster compared to standard treatments. This approach is less invasive than traditional surgery, which means it could lead to fewer risks and shorter hospital stays for patients.

To be eligible for the trial, participants need to be 18 years or older, have a history of Roux-en-Y surgery, and be experiencing symptoms like stomach pain, nausea, or vomiting. They must also be willing to undergo the endoscopy and follow the recommended treatment plan. If someone joins the study, they can expect to attend follow-up appointments at 4 and 8 weeks after the procedure to monitor their healing. Overall, this trial aims to improve treatment options for marginal ulcers and could lead to better care for other similar gastrointestinal conditions in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.