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

Recruiting

• Conditions: Gastric Antral Vascular Ectasia

• Registration Number: NCT03525366
• Lead Sponsor: The University of Texas Health Science Center, Houston

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

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2016-01-04
• Study First Submitted QC: 2018-05-02
• Study First Posted: 2018-05-15
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-30
• Last Update Posted: 2021-10-04
• Primary Completion: 2022-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hemoglobin level	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	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	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.

Trial Locations

Locations (1)

Memorial Hermann Hospital; 🇺🇸 Houston, Texas, United States