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

NCT07169799 | Recruiting

• 1 other identifier: 25-002286
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Evaluate the clinical benefit of truFreeze® spray-cryotherapy in patients with gastric-antral vascular ectasia.

  Changes in mean hemoglobin concentrations. Total number of packed-RCB units during a 6-month period after treatment and 6-months prior to treatment (retrospective review)

  over 6 month period

Secondary Outcomes (1)

• Endoscopic success.

  over 6 month period

Study Arms (1)

Prospective arm: Spray Cryotherapy

OTHER

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

Other: trūFreeze® Spray Cryotherapy System (STERIS Endoscopy)

Interventions

trūFreeze® Spray Cryotherapy System (STERIS Endoscopy) 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.

Also known as: Procedure: EGD and truFreeze® spray-cryotherapy

Prospective arm: Spray Cryotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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) \[extendable to Hgb(T-9 mo) if 6-month data are incomplete\]

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Gastric Antral Vascular Ectasia

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Angiodysplasia; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Swathi Eluri, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie McNew

CONTACT

904-953-0580; mcnew.stephanie@mayo.edu

Kristen Lozano

CONTACT

lozano.kristen@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Open-label, single-arm pre-post study with a 1:2 matched historical control cohort

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: September 12, 2025
• Study Start (Estimated): September 22, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)