Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06543316 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Marginal Ulcer Healing With Low-Thermal Argon Plasma Endoscopic Treatment

Study acronym: AMULET
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Primary completion date: Feb 2026 to Dec 2027
    • Study completion date: Apr 30, 2027 to Jun 2028
    v4
  2. Minor Start date changed from estimate of Feb 2025 to Mar 4, 2025
    • Site contact updated
    v3
  3. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Start date: Nov 1, 2024 to Feb 2025
    • Primary completion date: Oct 31, 2025 to Feb 2026
    • Study completion date: Apr 30, 2026 to Apr 30, 2027
    • Site details revised
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06543316
Lead Sponsor Christopher C. Thompson, MD, MSc
Collaborators: Erbe USA Incorporated
Conditions
(from sponsor)
Roux-en-y Anastomosis Site, Marginal Ulcer, Marginal Ulcer (Peptic) or Erosion, Ulcer, Ulcer, Gastric, Ulcer Gastrointestinal, Abdominal Pain, Nausea +4 more
Related terms Abdominal Pain, Deglutition Disorders, Gastrointestinal Hemorrhage, Nausea, Peptic Ulcer, Stomach Ulcer, Ulcer, Vomiting
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov