Cryotherapy for GAVE
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the trūFreeze® Spray Cryotherapy System, a type of cryotherapy, to determine its effectiveness for individuals with gastric antral vascular ectasia (GAVE), a condition that causes stomach bleeding. Researchers aim to discover if the treatment can improve blood levels and reduce the need for blood transfusions over six months. It suits those diagnosed with GAVE who have required blood transfusions in the past six months and have not undergone more than three previous treatments for GAVE. As an unphased trial, this study provides an opportunity to contribute to medical research and potentially benefit from an innovative treatment.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that the trūFreeze® Spray Cryotherapy System is safe for treating gastric antral vascular ectasia?
Research has shown that the trūFreeze® Spray Cryotherapy System is generally safe for treating issues in the digestive tract. Previous studies on cryotherapy for bleeding caused by gastric antral vascular ectasia (GAVE) suggest that patients tolerate it well.
Cryotherapy uses extreme cold to remove unwanted tissue and is already applied to various non-cancerous and cancerous conditions in the digestive system. Although specific data on side effects is limited, the technology's use in other treatments indicates a level of safety. For those considering joining the trial, this background suggests the treatment has undergone careful safety evaluation in similar conditions.12345Why are researchers excited about this trial?
Researchers are excited about cryotherapy for GAVE because it takes a novel approach by using extreme cold to treat the condition. Unlike traditional treatments like endoscopic electrocautery or argon plasma coagulation, which use heat to cauterize the bleeding lesions, cryotherapy involves freezing the tissue. This method may result in less tissue damage and potentially fewer side effects, offering a gentler alternative for patients. Additionally, the trūFreeze® Spray Cryotherapy System is non-invasive and can be precisely targeted, making it a promising option for those with gastric antral vascular ectasia.
What evidence suggests that the trūFreeze® Spray Cryotherapy System is effective for GAVE?
Research shows that the trūFreeze Spray Cryotherapy System, which uses liquid nitrogen, effectively treats certain stomach and intestinal issues. Studies have found that this treatment benefits patients who haven't improved with other methods like radiofrequency ablation. In this trial, participants will receive the trūFreeze Spray Cryotherapy System for gastric antral vascular ectasia (GAVE). The treatment targets the unusual blood vessels in the stomach lining that cause bleeding. By freezing these vessels, it can reduce bleeding and improve symptoms. Early results indicate that patients receiving this treatment have better hemoglobin levels and require fewer blood transfusions. This offers a promising option for people dealing with GAVE.24678
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive cryotherapy spray treatment for eradication of gastric antral vascular ectasia
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- trūFreeze® Spray Cryotherapy System
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor