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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ • 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.

Locations
United States
Florida
Mayo Clinic in Florida
RECRUITING
Jacksonville
Contact Information
Primary
Stephanie McNew
mcnew.stephanie@mayo.edu
904-953-0580
Backup
Kristen Lozano
lozano.kristen@mayo.edu
Time Frame
Start Date: 2026-09-22
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 50
Treatments
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.
Sponsors
Leads: Mayo Clinic

This content was sourced from clinicaltrials.gov