RecruitingNot ApplicableNCT06543316

Marginal Ulcer Healing With Low-Thermal Argon Plasma Endoscopic Treatment

Accelerated Marginal Ulcer Healing With Low-Thermal Argon Plasma Endoscopic Treatment

Sponsor

Christopher C. Thompson, MD, MSc

Enrollment

100 participants

Start Date

Mar 4, 2025

Study Type

INTERVENTIONAL

Conditions

Vomiting Ulcer Nausea Marginal Ulcer Ulcer, Gastric Roux-en-y Anastomosis Site Marginal Ulcer (Peptic) or Erosion Ulcer Gastrointestinal Abdominal Pain

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria8

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 Criteria7

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.

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Interventions

PROCEDURELow Thermal Plasma (LTP) Treatment

For 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.

OTHERStandard of Care Ulcer Treatment (typically PPI Administration)

Standard 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.