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

Официальное название

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

Обзор

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

Вмешательства

• Другое trūFreeze® Spray Cryotherapy System (STERIS Endoscopy)
  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.

Первичные конечные точки

• Evaluate the clinical benefit of truFreeze® spray-cryotherapy in patients with gastric-antral vascular ectasia. [Срок оценки: over 6 month period]

Вторичные конечные точки (1)

• Endoscopic success. [Срок оценки: over 6 month period]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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 ≤ 40.
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Mayo Clinic in Florida — Jacksonville

Идентификаторы

NCT: NCT07169799 · 25-002286

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗