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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03525366
Recruitment Status : Recruiting
First Posted : May 15, 2018
Last Update Posted : October 4, 2021
Sponsor:
Information provided by (Responsible Party):
Nirav C Thosani, The University of Texas Health Science Center, Houston

Study Description
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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.


Condition or disease Intervention/treatment
Gastric Antral Vascular Ectasia Other: Radiofrequency ablation

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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Year
Official Title: Prospective Evaluation Of Outcomes For Patients Undergoing Radiofrequency Ablation (RFA) Using HALO Ultra Device For Gastric Antral Vascular Ectasia (GAVE)
Study Start Date : August 2015
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine


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

Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. Hemoglobin level [ Time Frame: Before the first RFA session with HALO ULTRA device. ]
  3. 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.

  4. Number of patients who require blood transfusion [ Time Frame: Before the first RFA session with HALO ULTRA device ]
  5. 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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with Gastric Antral Valve Ectasia cohort undergoing radiofrequency ablation therapy
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03525366


Contacts
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Contact: Prithvi B Patil, MS 713-500-6654 prithvi.b.patil@uth.tmc.edu
Contact: Nirav Thosani, MD 7135006457 nirav.thosani@uth.tmc.edu

Locations
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United States, Texas
Memorial Hermann Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Prithvi Patil, MS    713-500-6654    prithvi.b.patil@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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Principal Investigator: Nirav Thosani, MD MHA The University of Texas Health Science Center, Houston
More Information
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Additional Information:

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Responsible Party: Nirav C Thosani, Assistant Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT03525366    
Other Study ID Numbers: HSC-MS-15-0449
First Posted: May 15, 2018    Key Record Dates
Last Update Posted: October 4, 2021
Last Verified: September 2021
Additional relevant MeSH terms:
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Gastric Antral Vascular Ectasia
Dilatation, Pathologic
Pathological Conditions, Anatomical
Stomach Diseases
Gastrointestinal Diseases
 Digestive System Diseases
Angiodysplasia
Vascular Diseases
Cardiovascular Diseases