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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prospective arm: Spray Cryotherapy | Other | Subjects to receive baseline endoscopic confirmation/classification of GAVE, laboratory panels, and clinical indices. Once confirmed, subjects will undergo cryotherapy procedure schedule. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the clinical benefit of truFreeze® spray-cryotherapy in patients with gastric-antral vascular ectasia. | Changes in mean hemoglobin concentrations. Total number of packed-RCB units during a 6-month period after treatment and 6-months prior to treatment (retrospective review) | over 6 month period |
| Measure | Description | Time Frame |
|---|---|---|
| Endoscopic success. | Endoscopic success (as assessed by independent endoscopic image review) measured safety of the cryotherapy procedure (adverse event tracking and assessments) change in means of patient's quality of life (measured by SF-12) | over 6 month period |
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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:
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:
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
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stephanie McNew | Contact | 904-953-0580 | mcnew.stephanie@mayo.edu | |
| Kristen Lozano | Contact | lozano.kristen@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Swathi Eluri, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Florida | Recruiting | Jacksonville | Florida | 32224 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D020252 | Gastric Antral Vascular Ectasia |
| ID | Term |
|---|---|
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D016888 | Angiodysplasia |
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Open-label, single-arm pre-post study with a 1:2 matched historical control cohort
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| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |