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Procedure

Low Thermal Plasma for Marginal Ulcers (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 able to tolerate repeated endoscopic procedures
Be older than 18 years old
Must not have
Inability to provide informed consent
Unwillingness to undergo repeated endoscopies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 4 weeks, 8 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to study a new treatment for marginal ulcers using Low Thermal Plasma during an endoscopy. The treatment involves using argon plasma with low power settings to shrink the ulcers and speed

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
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I can undergo multiple endoscopies.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am unable to understand or sign the consent form.
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I am not willing to have multiple endoscopies.
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I am currently taking antibiotics.
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I am not pregnant, breastfeeding, and I use reliable birth control.

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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).

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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
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