Status:
WITHDRAWN
Cryotherapy for GAVE
Lead Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Collaborating Sponsors:
Long Island Jewish Medical Center
Geisinger Clinic
Conditions:
GAVE - Gastric Antral Vascular Ectasia
Bleeding
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
Gastric antral vascular ectasia (GAVE) is a condition that can lead to blood loss in the gastrointestinal tract and low blood counts or anemia. 1,2 GAVE is commonly associated with liver disease, kidn...
Detailed Description
Gastric antral vascular ectasia (GAVE), classically termed "watermelon stomach," is a condition of chronic acute blood loss in the gastrointestinal (GI) tract and can lead to common utilization of pac...
Eligibility Criteria
Inclusion
- Have GAVE
- Have had treatment discussion with non-study team member (physician or GI advanced practice provider) of alternatives and have elected Cryotherapy
- Patients with signs of GI bleeding defined as hemoglobin drop \> 2 grams/dL, need for PRBC transfusion or overt bleeding (melena, hematemesis, hematochezia)
- Patients undergoing EGD with Ablation for GAVE (treatment naïve, RFA, banding, APC failures)
- Patients who underwent their last ablation at least 4 weeks prior
- Platelet count \> 40,000
- International normalized ratio (INR) \< 1.5
- Age \> 18 years and \< 90 years
Exclusion
- Age \< 18 years OR \> 90 years
- Inability to obtain consent
- Anticoagulants or anti-platelet agents use (excluding aspirin) within the last 7-10 days
- Platelet count \< 40,000
- INR \> 1.5
Key Trial Info
Start Date :
October 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 22 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04760873
Start Date
October 14 2020
End Date
January 22 2024
Last Update
December 5 2024
Active Locations (5)
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1
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
2
Long Island Jewish Medical Center
New Hyde Park, New York, United States, 11040
3
Columbia University Medical Center-NYPH
New York, New York, United States, 10032
4
Cleveland Clinic Foundation of America
Cleveland, Ohio, United States, 44195