Prospective Evaluation Of Outcomes For Patients Undergoing Radiofrequency Ablation (RFA) Using HALO Ultra Device For Gastric Antral Vascular Ectasia (GAVE)
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 4/5/2019 |
| Start Date: | August 2015 |
| End Date: | December 2025 |
| Contact: | Prithvi B Patil, MS |
| Email: | prithvi.b.patil@uth.tmc.edu |
| Phone: | 713-500-6654 |
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.
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
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
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
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