Cryotherapy Spray for Gastric Antral Vascular Ectasia
trūFreeze® Spray Cryotherapy System (STERIS Endoscopy)
Cardiovascular Diseases+4
+ Digestive System Diseases
+ Gastrointestinal Diseases
Treatment Study
Summary
Study start date: September 22, 2026
Actual date on which the first participant was enrolled.This study focuses on understanding how cryotherapy spray treatment, known as Tru-Freeze, can help manage a condition called gastric antral vascular ectasia (GAVE). GAVE is an issue where the lining of the stomach has abnormal blood vessels, leading to bleeding and anemia. The goal is to see if using cryotherapy spray can reduce the need for blood transfusions and improve hemoglobin levels, which are indicators of blood health, over a period of six months. This research is important because it could provide a less invasive option for people suffering from GAVE and potentially improve their quality of life by reducing the frequency and severity of bleeding episodes. Participants in the study will receive cryotherapy treatment, which involves spraying a cold substance directly onto the affected area of the stomach. This treatment aims to freeze and remove the problematic blood vessels. The study will monitor participants' hemoglobin levels and how often they need blood transfusions over the six months following treatment. By comparing these results with the six months prior to receiving cryotherapy, the study seeks to determine the effectiveness of the treatment. While the study does not specify particular risks or benefits, cryotherapy is generally considered a safe procedure with minimal discomfort involved.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.50 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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: * 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. 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 * 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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location