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

Gastric Antral Vascular Ectasia Clinical Trial

— GAVE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03525366
• Other study ID #: HSC-MS-15-0449
• Status: Recruiting
• Start date: August 2015
• Est. completion date: December 2025

Study information

• Verified date: September 2021
• Source: The University of Texas Health Science Center, Houston
• Contact: Prithvi B Patil, MS
• Phone: 713-500-6654
• Email: prithvi.b.patil[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2025
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastric Antral Vascular Ectasia

Intervention

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

Locations

Country	Name	City	State
United States	Memorial Hermann Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Hemoglobin level		Before the first RFA session with HALO ULTRA device.
Primary	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.
Primary	Number of patients who require blood transfusion		Before the first RFA session with HALO ULTRA device
Primary	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.