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Procedure

Argon Plasma for Helicobacter Pylori Infection (HEAPE Trial)

N/A

Waitlist Available

Led By Christopher C Thompson, MD

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 must be 18 years or older

Be older than 18 years old

Must not have

Hernias / aspiration risk

An inability to provide informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 hours post-treatment, 4 weeks post-treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test a new treatment called HEAPE, which uses argon plasma to treat H. pylori infections in the stomach during endoscopic procedures. The study will compare two methods of generating

Who is the study for?

This trial is for individuals with H. pylori infection, which can cause stomach ulcers and other gastrointestinal issues. Participants should be suitable for endoscopic procedures. The study excludes those who may not safely undergo the procedure or have conditions that could interfere with treatment outcomes.

What is being tested?

The trial tests a new argon plasma-based therapy called HEAPE to treat H. pylori during endoscopy, comparing two methods: direct application in the stomach (HEAPE direct) and pre-treatment outside the body (Pre-HEAPE). It aims to see if this can reduce bacteria levels without thermal damage.

What are the potential side effects?

Since HEAPE avoids thermal ablation of the stomach lining, side effects are expected to be minimal. However, potential risks may include typical endoscopy-related complications such as discomfort or minor bleeding.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a hernia or am at risk of aspiration.

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I am unable to understand and give consent for treatment.

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I do not have severe heart or lung disease, recent heart attacks, uncontrolled high blood pressure, or a need for NSAIDs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 hours post-treatment, 4 weeks post-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 hours post-treatment, 4 weeks post-treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 hours post-treatment, 4 weeks post-treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Reduction in H. pylori load from baseline to 2 hours after treatment using Urea Breath Test

Secondary study objectives

Adverse Events intra-procedural and post-treatment

Change in dyspepsia symptoms from baseline via patient self-report of symptoms

Change in epigastric pain level from baseline via patient self-report of symptoms using the Abdominal Pain Index

+5 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: Pre-HEAPEActive Control1 Intervention

This modality features the treatment of sodium chloride with APC outside of the patient in a sterile container. After the APC treatment, the generated PAL is administered into the stomach with a syringe through the working channel of the endoscope. Pre-HEAPE allows an easier handling of the APC probe as the treatment of the sodium chloride solution can be done without an endoscope.

Group II: HEAPE directActive Control1 Intervention

This modality is the direct generation of PAL in the stomach. The stomach is filled with sodium chloride solution which is then treated with APC. With HEAPE direct a potential decrease of reactive species is avoided, as the treatment happens directly at the intended location in the H. pylori infected stomach.

0 / 4Eligibility criteria met