Cryotherapy spray (truFreeze) to eradicate gastric antral vascular ectasia.
Official title: Evaluating the Impact of Cryotherapy Spray (Tru-Freeze) for the Eradication of Gastric Antral Vascular Ectasia (ICE-GAVE)
Run by Mayo Clinic · NCT07169799 · Data updated 2026-11-12
This will try a cryotherapy spray (truFreeze) to see if it reduces bleeding and lowers blood transfusion needs in adults with antral‑predominant GAVE and recent transfusion‑dependent anemia.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Jacksonville, Florida) |
| Status | Recruiting |
| Started | December 22, 2026 |
| Main results expected | September 30, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | April 3, 2026 |
| Trial ID | NCT07169799 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with endoscopically confirmed antral‑predominant GAVE who have needed at least one packed red blood cell transfusion for GAVE‑related bleeding within the past six months are ideal candidates.
✕Probably not a fit
Patients with diffuse portal‑hypertensive gastropathy, non‑antral GAVE, or without recent transfusion‑dependent bleeding are unlikely to benefit from this antrum‑focused cryotherapy approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults with endoscopically confirmed antral‑predominant GAVE and recent transfusion‑dependent anemia will receive endoscopic spray cryotherapy using the truFreeze system applied to the affected antral mucosa. The study compares hemoglobin levels and transfusion requirements in the six months after cryotherapy to the six months before treatment. Participants may be treatment‑naïve or have had up to three prior endoscopic therapies and will have scheduled blood checks and clinical follow-up. The primary outcomes are change in hemoglobin and the number of packed red blood cell transfusions required.
Why it matters
Potential benefit: If successful, the treatment could raise hemoglobin, reduce gastrointestinal bleeding, and decrease the need for blood transfusions in patients with antral GAVE.
How similar studies have gone: Small case series and retrospective reports have suggested endoscopic cryotherapy can control bleeding from GAVE, but high‑quality prospective data are limited.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Mayo Clinic in Florida
Jacksonville, Florida, United States Recruiting
Study contacts
- Principal investigator: Swathi Eluri, M.D. — Mayo Clinic
- Study coordinator: Stephanie McNew
- Email: mcnew.stephanie@mayo.edu
- Phone: 904-953-0580
Similar studies
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Understanding gastric issues in patients with enlarged stomach blood vessels
This study is trying to see how often stomach problems like pain and nausea happen in adults with a condition called Gastric Antral Vascular Ectasia and how these issues relate to how well their stomachs work.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.