Recruiting

Cryotherapy Spray for Gastric Antral Vascular Ectasia

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What is being tested

trūFreeze® Spray Cryotherapy System (STERIS Endoscopy)

Other
Who is being recruted

Cardiovascular Diseases+4

+ Digestive System Diseases

+ Gastrointestinal Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: September 2026
See protocol details

Summary

Principal SponsorMayo Clinic
Study ContactStephanie McNewMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 22, 2026

Actual date on which the first participant was enrolled.

This study focuses on understanding how cryotherapy spray treatment, known as Tru-Freeze, can help manage a condition called gastric antral vascular ectasia (GAVE). GAVE is an issue where the lining of the stomach has abnormal blood vessels, leading to bleeding and anemia. The goal is to see if using cryotherapy spray can reduce the need for blood transfusions and improve hemoglobin levels, which are indicators of blood health, over a period of six months. This research is important because it could provide a less invasive option for people suffering from GAVE and potentially improve their quality of life by reducing the frequency and severity of bleeding episodes. Participants in the study will receive cryotherapy treatment, which involves spraying a cold substance directly onto the affected area of the stomach. This treatment aims to freeze and remove the problematic blood vessels. The study will monitor participants' hemoglobin levels and how often they need blood transfusions over the six months following treatment. By comparing these results with the six months prior to receiving cryotherapy, the study seeks to determine the effectiveness of the treatment. While the study does not specify particular risks or benefits, cryotherapy is generally considered a safe procedure with minimal discomfort involved.

Official TitleEvaluating the Impact of Cryotherapy Spray (Tru-Freeze) for the Eradication of Gastric Antral Vascular Ectasia (ICE-GAVE)
NCT07169799
Principal SponsorMayo Clinic
Study ContactStephanie McNewMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesVascular DiseasesAngiodysplasiaGastric Antral Vascular Ectasia

Criteria

Inclusion Criteria • Diagnosis of antral-predominant GAVE: Endoscopic confirmation of gastric-antral vascular ectasia affecting the antrum, without severe portal-hypertensive gastropathy. Sub-classify as nodular or non-nodular GAVE. * Age: ≥ 18 years at the time of consent. * Recent transfusion-dependent anemia * ≥ 1 packed-RBC transfusion for GAVE-related bleeding within the last 6 months to maintain hemoglobin (Hgb) \> 8 g/dL (or \> 7 g/dL if no coronary/vascular disease). * Standard-of-care transfusion thresholds: * If no coronary artery/vascular disease (CVD): transfuse 2 units when Hgb \< 7 g/dL. * If CVD present: transfuse 2 units when Hgb \< 8 g/dL. * After any transfusion, re-check Hgb within 1 week and repeat transfusion per the same criteria as needed. * Documented transfusion history: o Medical records must show indication that each transfusion was for presumed GAVE-related bleeding. * Treatment status: o Either treatment-naïve or ≤ 3 prior endoscopic ablation sessions for GAVE. * Baseline data availability: Participant records must include endoscopic treatment dates, hemoglobin values, and transfusion data for 6 months prior to enrollment (extension up to 9 months permitted if data unavailable). Required elements: * total number of transfusions, * total number of prior endoscopic treatments, and calculated change in hemoglobin from baseline: Δ Hgb = Hgb(T-6 mo) - Hgb(T0) \[extendable to Hgb(T-9 mo) if 6-month data are incomplete\] * Capacity to consent: Able and willing to provide written informed consent. Exclusion Criteria * Other gastrointestinal pathology o Active peptic-ulcer disease, inflammatory bowel disease, severe portal-hypertensive gastropathy, or untreated esophageal/gastric varices. * Coagulopathy o Known bleeding disorder or acquired coagulopathy not attributable to GAVE. * Severe comorbidity / high procedural risk * Advanced heart failure, severe renal impairment, or any condition classified ASA IV or V. * Estimated life-expectancy \< 6 months. * Karnofsky performance status ≤ 40. * Deemed unfit for endoscopic procedures by the treating physician. * Pregnancy / lactation: o Pregnant or breastfeeding, or planning pregnancy within 6 months of consent. * Prior incompatible therapy o Previous cryoballoon ablation for GAVE. * Ability to participate * Unable or unwilling to comply with the protocol or follow-up schedule. * Unable or unwilling to provide written informed consent.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Mayo Clinic in Florida

Jacksonville, United StatesOpen Mayo Clinic in Florida in Google Maps
Recruiting
One Study Center