Impact of Cryotherapy Spray (Tru-Freeze) for the Eradication of Gastric Antral Vascular Ectasia (… (NCT07169799) | Clinical Trial Compass
RecruitingNot Applicable
Impact of Cryotherapy Spray (Tru-Freeze) for the Eradication of Gastric Antral Vascular Ectasia (ICE-GAVE)
United States50 participantsStarted 2026-12-22
Plain-language 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
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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) \[extendable to Hgb(T-9 mo) if 6-month data are incomplete\]
* …
What they're measuring
1
Evaluate the clinical benefit of truFreeze® spray-cryotherapy in patients with gastric-antral vascular ectasia.