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

NCT03525366 | Withdrawn

• 1 other identifier: HSC-MS-15-0449
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Antral Vascular Ectasia

Outcome Measures

Primary Outcomes (5)

• Number of RFA therapy sessions 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

  Before the first RFA session with HALO ULTRA device.

• Hemoglobin level

  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

  Before the first RFA session with HALO ULTRA device

• Number of patients who require blood transfusion

  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.

Interventions

Radiofrequency ablation OTHER

Radiofrequency Ablation (RFA) as an intervention is part of standard of care at Memorial Herman Hospital, Houston.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• In-patients
• Patients diagnosed with GAVE
• Patients undergoing radiofrequency ablation with HALO ULTRA device

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Gastric Antral Vascular Ectasia

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Angiodysplasia; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Nirav Thosani, MD MHA

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 4, 2016
• First Posted: May 15, 2018
• Study Start: August 1, 2015
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2025
• Last Updated: August 17, 2025

Record last verified: 2025-08

Locations

US (1)