Actively Recruiting
Impact of Cryotherapy Spray (Tru-Freeze) for the Eradication of Gastric Antral Vascular Ectasia (ICE-GAVE)
Led by Mayo Clinic · Updated on 2026-04-03
50
Participants Needed
1
Research Sites
105 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Impact of Cryotherapy Spray (Tru-Freeze) for the Eradication of Gastric Antral Vascular Ectasia (ICE-GAVE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of antral-predominant gastric antral vascular ectasia confirmed by endoscopy, without severe portal-hypertensive gastropathy
- Age 18 years or older at the time of consent
- Recent transfusion-dependent anemia with at least 1 packed red blood cell transfusion for GAVE-related bleeding within the last 6 months to maintain hemoglobin > 8 g/dL (or > 7 g/dL if no coronary or vascular disease)
- Medical records documenting each transfusion was for presumed GAVE-related bleeding
- Treatment-nafve or received 3 or fewer prior endoscopic ablation sessions for GAVE
- Available baseline data including endoscopic treatment dates, hemoglobin values, and transfusion data for 6 months prior to enrollment (extendable to 9 months if needed)
- Able and willing to provide written informed consent
You will not qualify if you...
- Presence of other gastrointestinal diseases such as active peptic-ulcer disease, inflammatory bowel disease, severe portal-hypertensive gastropathy, or untreated esophageal/gastric varices
- Known bleeding disorder or acquired coagulopathy not related to GAVE
- Severe comorbid conditions including advanced heart failure, severe renal impairment, ASA class IV or V, estimated life expectancy less than 6 months, or Karnofsky performance status of 40 or lower
- Deemed unfit for endoscopic procedures by the treating physician
- Pregnant, breastfeeding, or planning pregnancy within 6 months of consent
- Previous cryoballoon ablation treatment for GAVE
- Unable or unwilling to comply with the study protocol or follow-up schedule
- Unable or unwilling to provide written informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
Actively Recruiting
Research Team
S
Stephanie McNew
CONTACT
K
Kristen Lozano
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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