Clinical Trials

Inclusion Criteria: 

• Diagnosis of antral predominant GAVE: Confirmed through endoscopic examination in the absence of known severe portal hypertensive gastropathy. Sub-classification of GAVE as nodular or non-nodular.
• Age: Patients aged 18 years and older.
• Hemoglobin Levels: Patients who have required at least one blood transfusion to maintain hemoglobin levels greater than 8 mg/dL in the past 6 months (or 7mg/dl with CVD)
• Transfusion History: Documented history of blood transfusions due to GAVE-related bleeding. Criteria for transfusion is standard of care. If no coronary artery/vascular disease, transfuse 2 units if Hgb < 7mg/dl. If CVD, then transfusion 2 units
• Hgb < 8mg/dl. If transfusion is administered, recheck Hgb within 1 week and re-transfusion using same criteria as needed.
• Consent: Patients must provide informed consent to participate in the study.
• Treatment naïve or prior ablation (<3 prior ablation sessions)
• Availability of endoscopic treatment, Hgb and transfusion data for the 6-9 months prior to enrollment
  • Change in hemoglobin T-(6 allow up to 9) months – Hgb-T0
  • Number of endoscopic treatments
  • Number of transfusions received.

Exclusion Criteria: 

• Other Gastrointestinal Conditions: Significant conditions that could affect the study outcomes (e.g., active peptic ulcer disease, inflammatory bowel disease, severe portal hypertensive gastropathy, untreated varices).
• Coagulopathy: Known bleeding disorders or coagulopathies unrelated to GAVE.
• Severe Comorbidities: Severe conditions that could interfere with the study or pose a high-risk during treatment (e.g., advanced heart failure, severe renal impairment).
  • ASA 4-5
  • Life expectancy < 6 months.
• Pregnancy: Pregnant or breastfeeding women or anticipated within 6 months of consent.
• Non-Compliance: Patients unable or unwilling to comply with the study protocol and follow-up requirements.
• Patients unwilling or unable to provide consent
• Karnofsky performance status (Greater than 40)
• Patients unfit for endoscopic procedures
• Patients that have undergone previous cryoballoon procedures for treatment of GAVE.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 2/27/2025. Questions regarding updates should be directed to the study team contact.