Cryotherapy for GAVE

Overseen By Stephanie McNew

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Peptic ulcers, IBD, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to evaluate the impact of cryotherapy spray treatment for eradication of gastric antral vascular ectasia by measuring the change in hemoglobin levels and transfusion requirements in the first 6 months of cryotherapy treatment compared to the previous 6 months

Who Is on the Research Team?

Swathi Eluri, M.D.

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a condition called GAVE, which can cause stomach bleeding. They must have had blood transfusions due to GAVE and no more than three previous treatments for it. Participants need documented medical history and the ability to consent. Pregnant women, those with severe other illnesses or short life expectancy, or who cannot follow the study plan are excluded.

Inclusion Criteria

Documented transfusion history for presumed GAVE-related bleeding

Baseline data availability including specific records for 6 months prior to enrollment

My stomach condition was confirmed by a camera test.

Exclusion Criteria

Deemed unfit for endoscopic procedures by the treating physician

Estimated life-expectancy < 6 months

Pregnancy/lactation or planning pregnancy within 6 months of consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive cryotherapy spray treatment for eradication of gastric antral vascular ectasia

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• trūFreeze® Spray Cryotherapy System

Trial Overview The trial tests if a cryotherapy spray (Tru-Freeze) can improve hemoglobin levels and reduce the need for blood transfusions in patients with GAVE by comparing their health before and after six months of treatment.

How Is the Trial Designed?

Group I: Prospective arm: Spray Cryotherapy Experimental Treatment 1 Intervention

Subjects to receive baseline endoscopic confirmation/classification of GAVE, laboratory panels, and clinical indices. Once confirmed, subjects will undergo cryotherapy procedure schedule.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+