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

September 30, 2021 updated by: Nirav C Thosani, The University of Texas Health Science Center, Houston

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients with Gastric Antral Valve Ectasia cohort undergoing radiofrequency ablation therapy

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of RFA therapy sessions with the HALO ULTRA device
Time Frame: 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.
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.
Before the first RFA session with HALO ULTRA device.
Hemoglobin level
Time Frame: 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.
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
Before the first RFA session with HALO ULTRA device
Number of patients who require blood transfusion
Time Frame: 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.
At the time of resolution of GAVE lesions, which is up to 1 year after first RFA session with HALO ULTRA device.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Investigators

  • Principal Investigator: Nirav Thosani, MD MHA, The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

January 4, 2016

First Submitted That Met QC Criteria

May 2, 2018

First Posted (Actual)

May 15, 2018

Study Record Updates

Last Update Posted (Actual)

October 4, 2021

Last Update Submitted That Met QC Criteria

September 30, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-MS-15-0449

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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