Impact of Cryotherapy Spray (Tru-Freeze) for the Eradication of Gastric Antral Vascular Ectasia (ICE-GAVE)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: trūFreeze® Spray Cryotherapy System (STERIS Endoscopy).
- Who it may be relevant to
- Registry conditions: Gastric Antral Vascular Ectasia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluating the Impact of Cryotherapy Spray (Tru-Freeze) for the Eradication of Gastric Antral Vascular Ectasia (ICE-GAVE)
Overview
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
Interventions
- Other trūFreeze® Spray Cryotherapy System (STERIS Endoscopy)
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.
Primary outcome measures
- Evaluate the clinical benefit of truFreeze® spray-cryotherapy in patients with gastric-antral vascular ectasia. [Time frame: over 6 month period]
Secondary outcome measures (1)
- Endoscopic success. [Time frame: over 6 month period]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Mayo Clinic in Florida — Jacksonville
Identifiers
NCT: NCT07169799 · 25-002286