Gastric Antral Vascular Ectasia
Conditions
Brief summary
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.
Detailed description
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
Interventions
OTHERRadiofrequency ablation
Radiofrequency Ablation (RFA) as an intervention is part of standard of care at Memorial Herman Hospital, Houston.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* In-patients * Patients diagnosed with GAVE * Patients undergoing radiofrequency ablation with HALO ULTRA device
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of RFA therapy sessions with the HALO ULTRA device | 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. |
| Hemoglobin level | Before the first RFA session with HALO ULTRA device. | — |
| Number of patients who require blood transfusion | Before the first RFA session with HALO ULTRA device | — |
Countries
United States
Outcome results
None listed