Impact of Cryotherapy Spray (Tru-Freeze) for the Eradication of Gastric Antral Vascular Ectasia (ICE-GAVE)

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
Mayo Clinic
Study ID
NCT07169799
Status
Recruiting
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Conditions

  • Gastric Antral Vascular Ectasia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • trūFreeze® Spray Cryotherapy System (STERIS Endoscopy) — OTHER
    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.

Study Details

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

Key Dates

Start date
Dec 22, 2026
Status verified
Mar 2026
Primary completion
Sep 30, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Prospective arm: Spray Cryotherapy
    Subjects to receive baseline endoscopic confirmation/classification of GAVE, laboratory panels, and clinical indices. Once confirmed, subjects will undergo cryotherapy procedure schedule.

Primary Outcome Measure

Evaluate the clinical benefit of truFreeze® spray-cryotherapy in patients with gastric-antral vascular ectasia. [ Time Frame: over 6 month period ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in FloridaJacksonvilleFlorida32224
Stephanie McNew, B.S.
[email protected]
904-953-0580
Swathi Eluri, M.D. (PRINCIPAL_INVESTIGATOR)

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Mayo Clinic in Florida· Jacksonville, FL

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