Marginal Ulcer Healing With Low-Thermal Argon Plasma Endoscopic Treatment

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Christopher C. Thompson, MD, MSc
Study ID
NCT06543316
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Low Thermal Plasma (LTP) Treatment — PROCEDURE
    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.
  • Standard of Care Ulcer Treatment (typically PPI Administration) — OTHER
    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.

Study Details

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.

Key Dates

Start date
Mar 4, 2025
Status verified
Jul 2025
Primary completion
Feb 28, 2026
Completion
Apr 30, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Low Thermal Plasma (LTP)
    Patients randomized to this group will receive LTP treatment of the ulcer in addition to SOC (PPI administration).
  • Active Comparator: Standard of Care (SOC) PPI Administration
    Patients randomized to this group will receive only the SOC treatment (PPI administration).

Primary Outcome Measure

Ulcer Healing Success Rate from baseline endoscopy [ Time Frame: Baseline, 4 weeks, 8 Weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115
Michele B. Ryan, MS
[email protected]
6175258266
Christopher C. Thompson, MD, MSc (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By research site
Brigham and Women's Hospital· Boston, MA

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