Impact of Cryotherapy Spray (Tru-Freeze) for the Eradication of Gastric Antral Vascular Ectasia (ICE-GAVE)

NCT ID: NCT07169799

Last Updated: 2025-09-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-09-22
• Study Completion Date: 2028-12-31

Brief Summary

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

Conditions

Gastric Antral Vascular Ectasia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Prospective arm: Spray Cryotherapy

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

Group Type: OTHER

trūFreeze® Spray Cryotherapy System (STERIS Endoscopy)

Intervention Type: OTHER

This treatment consists of performing a diagnostic EGD to identify GAVE lesions. A catheter advances through the therapeutic channel to treat target areas with cryotherapy.

Interventions

trūFreeze® Spray Cryotherapy System (STERIS Endoscopy)

This treatment consists of performing a diagnostic EGD to identify GAVE lesions. A catheter advances through the therapeutic channel to treat target areas with cryotherapy.

Intervention Type: OTHER

Other Intervention Names

Procedure: EGD and truFreeze® spray-cryotherapy

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Swathi Eluri

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Swathi Eluri, M.D.

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Stephanie McNew

Role: CONTACT

mcnew.stephanie@mayo.edu

904-953-0580

Kristen Lozano

Role: CONTACT

lozano.kristen@mayo.edu

Facility Contacts

Stephanie McNew, B.S.

Role: primary

mcnew.stephanie@mayo.edu

904-953-0580

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

25-002286

Identifier Type: -

Identifier Source: org_study_id