Clinical trial NCT03525366: Prospective Evaluation Of Outcomes For Patients Undergoing Radiofrequency Ablation (RFA) Using HALO Ultra Device For Gastric Antral Vascular Ectasia (GAVE)
Official title: Prospective Evaluation Of Outcomes For Patients Undergoing Radiofrequency Ablation (RFA) Using HALO Ultra Device For Gastric Antral Vascular Ectasia (GAVE)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastric Antral Vascular Ectasia
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2018-05-15
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with Gastric Antral Valve Ectasia cohort undergoing radiofrequency ablation therapy

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.

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

Eligibility 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

Primary outcomes:
measure: Number of RFA therapy sessions with the HALO ULTRA device
timeFrame: Up to 1 year after first RFA session with the HALO ULTRA device
measure: Hemoglobin level
timeFrame: Before the first RFA session with HALO ULTRA device.
measure: Hemoglobin level
timeFrame: At the time of resolution of GAVE lesions, which is up to 1 year after first RFA session with HALO ULTRA device.
measure: Number of patients who require blood transfusion
timeFrame: Before the first RFA session with HALO ULTRA device
measure: Number of patients who require blood transfusion
timeFrame: At the time of resolution of GAVE lesions, which is up to 1 year after first RFA session with HALO ULTRA device.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Memorial Hermann Hospital
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Nirav Thosani, MD MHA
role: PRINCIPAL_INVESTIGATOR
References: