Prospective Evaluation Of Outcomes For Patients Undergoing Radiofrequency Ablation (RFA) Using HALO Ultra Device For Gastric Antral Vascular Ectasia (GAVE)

The University of Texas System (UT)

Status: Enrolling

Conditions: Gastric Antral Vascular Ectasia

Treatments: Other: Radiofrequency ablation

Study type: Observational

Funder types: Other

Identifiers

NCT03525366

HSC-MS-15-0449

Details and patient eligibility

About

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.

Full 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

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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