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.
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
Study Type
OBSERVATIONAL
Radiofrequency Ablation (RFA) as an intervention is part of standard of care at Memorial Herman Hospital, Houston.
Memorial Hermann Hospital
Houston, Texas, United States
Number of RFA therapy sessions 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.
Time frame: Up to 1 year after first RFA session with the HALO ULTRA device
Hemoglobin level
Time frame: Before the first RFA session with HALO ULTRA device.
Hemoglobin level
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.
Time frame: At the time of resolution of GAVE lesions, which is up to 1 year after first RFA session with HALO ULTRA device.
Number of patients who require blood transfusion
Time frame: Before the first RFA session with HALO ULTRA device
Number of patients who require blood transfusion
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.
Time frame: At the time of resolution of GAVE lesions, which is up to 1 year after first RFA session with HALO ULTRA device.
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