WithdrawnNot Applicable

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

Stopped: lack of funding

United States0Started 2015-08

Plain-language 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.

Who can participate

Age range

18 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of RFA therapy sessions with the HALO ULTRA device

Timeframe: Up to 1 year after first RFA session with the HALO ULTRA device

Hemoglobin level

Timeframe: Before the first RFA session with HALO ULTRA device.

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.

Number of patients who require blood transfusion

Timeframe: Before the first RFA session with HALO ULTRA device

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.

Trial details

NCT IDNCT03525366

SponsorThe University of Texas Health Science Center, Houston

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-12

View on ClinicalTrials.gov More Gastric Antral Vascular Ectasia trials

Plain-language summary

Who can participate

Age range

18 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of RFA therapy sessions with the HALO ULTRA device

Timeframe: Up to 1 year after first RFA session with the HALO ULTRA device

Hemoglobin level

Timeframe: Before the first RFA session with HALO ULTRA device.

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.

Number of patients who require blood transfusion

Timeframe: Before the first RFA session with HALO ULTRA device

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.