NCT07169799 Impact of Cryotherapy Spray (Tru-Freeze) for the Eradication of Gastric Antral Vascular Ectasia (ICE-GAVE)
| NCT ID | NCT07169799 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mayo Clinic |
| Condition | Gastric Antral Vascular Ectasia |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2026-12-22 |
| Primary Completion | 2028-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2026-12-22 with a primary completion date of 2028-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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.
Contact & Investigator
Swathi Eluri, M.D.
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT07169799 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Gastric Antral Vascular Ectasia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07169799 currently recruiting?
Yes, NCT07169799 is actively recruiting participants. Contact the research team at mcnew.stephanie@mayo.edu for enrollment information.
Where is the NCT07169799 trial being conducted?
This trial is being conducted at Jacksonville, United States.
Who is sponsoring the NCT07169799 clinical trial?
NCT07169799 is sponsored by Mayo Clinic. The principal investigator is Swathi Eluri, M.D. at Mayo Clinic. The trial plans to enroll 50 participants.