NCT07169799招募中不适用
Evaluating the Impact of Cryotherapy Spray (Tru-Freeze) for the Eradication of Gastric Antral Vascular Ectasia (ICE-GAVE)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Evaluate the clinical benefit of truFreeze® spray-cryotherapy in patients with gastric-antral vascular ectasia.
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
- •Advanced heart failure, severe renal impairment, or any condition classified ASA IV or V.
- •Estimated life-expectancy < 6 months.
- •Karnofsky performance status ≤
- •Deemed unfit for endoscopic procedures by the treating physician.
- •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
- •Unable or unwilling to comply with the protocol or follow-up schedule.
- •Unable or unwilling to provide written informed consent.
结局指标
主要结局
Evaluate the clinical benefit of truFreeze® spray-cryotherapy in patients with gastric-antral vascular ectasia.
时间窗: over 6 month period
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)
次要结局
- Endoscopic success.(over 6 month period)
研究者
研究点 (2)
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