Prospective Evaluation Of Outcomes For Patients Undergoing Radiofrequency Ablation (RFA) Using HALO Ultra Device For Gastric Antral Vascular Ectasia (GAVE)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Hemoglobin level
研究概览
简要总结
The purpose: To determine the safety and efficacy of Radiofrequency Ablation (RFA) HALO Ultra system in patients with Gastric Antral Vascular Ectasia patient cohort (GAVE).
Research design: This is a prospective observational study. Procedure Used: Radiofrequency Ablation
Risks and potential benefits:
There are no risks associated with this study as it is a retrospective chart review. Potential benefits include the knowledge gained from this study which may be of help to patients in the future.
Importance of knowledge that may reasonably be expected to result The knowledge gained from this study may be of help to other patients in the future.
详细描述
The purpose of this study is to see how well study device works at treating people with Gastric Antral Vascular Ectasia (GAVE). The device has already been approved by the Food and Drug Administration (FDA) and is a part of standard of care. You have been invited to join this research study because you require diagnostic or therapeutic evaluation of the Gastric Antral Vascular Ectasia by RFA.
This is a single -site study being performed at the University of Texas Health Science Center. The study will enroll a total 1000 patients with GAVE. This study is purely observational and will collect clinical information regarding your GAVE
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In-patients
- •Patients diagnosed with GAVE
- •Patients undergoing radiofrequency ablation with HALO ULTRA device
排除标准
- •Patients who were not diagnosed with GAVE
- •Patients undergoing RFA with HALO ULTRA device for diseases other than GAVE.
- •Patients with GAVE receiving other endoscopic therapies like argon plasma coagulation (APC) or radiofrequency ablation (RFA) with devices other than HALO ULTRA
结局指标
主要结局
Hemoglobin level
时间窗: At the time of resolution of GAVE lesions, which is up to 1 year after first RFA session with HALO ULTRA device.
Hemoglobin level will be assessed at the time the patient achieves resolution of Gastric Antral Vascular Ectasia (GAVE) lesions, which may be up to 1 year.
Number of patients who require blood transfusion
时间窗: At the time of resolution of GAVE lesions, which is up to 1 year after first RFA session with HALO ULTRA device.
Patients will be followed up until the time that they achieve resolution of Gastric Antral Vascular Ectasia (GAVE) lesions, which may be up to 1 year.
Number of RFA therapy sessions with the HALO ULTRA device
时间窗: Up to 1 year after first RFA session with the HALO ULTRA device
Patients will be followed up until the time that they achieve resolution of Gastric Antral Vascular Ectasia (GAVE) lesions, which may be up to 1 year.
次要结局
未报告次要终点
研究者
Nirav C Thosani
Assistant Professor
The University of Texas Health Science Center, Houston