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Procedure

Low Thermal Plasma (LTP) for Ulcer (AMULET Trial)

N/A
Waitlist Available
Research Sponsored by Christopher C. Thompson, MD, MSc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* 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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 4 weeks, 8 weeks
Awards & highlights

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.

Who is the study for?
This trial is for individuals with marginal ulcers, which can cause symptoms like gastrointestinal bleeding, vomiting, abdominal pain, and difficulty swallowing. Participants should have a history of Roux-en-Y anastomosis surgery that led to these ulcers.
What is being tested?
The study compares Low Thermal Plasma (LTP) treatment applied endoscopically to the ulcerated areas against standard care (typically PPIs). The goal is to see if LTP speeds up healing and reduces ulcer size more effectively than standard treatments.
What are the potential side effects?
Potential side effects are not explicitly listed but may include typical risks associated with endoscopic procedures such as discomfort at the treatment site, minor bleeding or infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 4 weeks, 8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 4 weeks, 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Ulcer Healing Success Rate from baseline endoscopy
Secondary study objectives
Change in quality of life score from baseline using the 12 item Short Form Survey (SF-12)
Clinical Improvement of Gastrointestinal Symptoms
Comparison of Time to Ulcer Healing between LTP and SOC groups
+2 more

Trial Design

2Treatment groups
Active Control
Group I: Low Thermal Plasma (LTP)Active Control2 Interventions
Patients randomized to this group will receive LTP treatment of the ulcer in addition to SOC (PPI administration).
Group II: Standard of Care (SOC) PPI AdministrationActive Control1 Intervention
Patients randomized to this group will receive only the SOC treatment (PPI administration).

Find a Location

Who is running the clinical trial?

Christopher C. Thompson, MD, MScLead Sponsor
5 Previous Clinical Trials
5,146 Total Patients Enrolled
Erbe USA IncorporatedOTHER
11 Previous Clinical Trials
1,151 Total Patients Enrolled
~67 spots leftby Oct 2025