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

Overview

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 Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Cross-Sectional
  • Study Primary Completion Date: December 2021

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

Interventions

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

Clinical Trial Outcome Measures

Primary Measures

  • 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.
  • Hemoglobin level
    • Time Frame: 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.
  • Number of patients who require blood transfusion
    • Time Frame: 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.

Participating in This Clinical Trial

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
  • Gender Eligibility: All

    Minimum Age: 18 Years

    Maximum Age: 100 Years

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • The University of Texas Health Science Center, Houston
    • Provider of Information About this Clinical Study
      • Principal Investigator: Nirav C Thosani, Assistant Professor – The University of Texas Health Science Center, Houston
    • Overall Official(s)
      • Nirav Thosani, MD MHA, Principal Investigator, The University of Texas Health Science Center, Houston
    • Overall Contact(s)
      • Prithvi B Patil, MS, 713-500-6654, prithvi.b.patil@uth.tmc.edu

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