Evaluating the effectiveness of a device for treating gastric bleeding
Prospective Evaluation Of Outcomes For Patients Undergoing Radiofrequency Ablation (RFA) Using HALO Ultra Device For Gastric Antral Vascular Ectasia (GAVE)
This study is testing if the HALO Ultra device can safely and effectively treat gastric bleeding in patients with Gastric Antral Vascular Ectasia.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | The University of Texas Health Science Center, Houston Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT03525366 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the safety and efficacy of the HALO Ultra device for radiofrequency ablation in patients diagnosed with Gastric Antral Vascular Ectasia (GAVE). It will enroll 1000 in-patients undergoing this procedure, collecting clinical data to evaluate outcomes. The HALO Ultra device is FDA-approved and part of standard care for this condition. The study is being conducted at the University of Texas Health Science Center.
Who should consider this trial
Good fit: Ideal candidates are in-patients diagnosed with GAVE who are undergoing radiofrequency ablation with the HALO Ultra device.
Not a fit: Patients not diagnosed with GAVE or those receiving alternative therapies for GAVE will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment options for patients suffering from gastric bleeding due to GAVE.
How similar studies have performed: While this approach is based on an FDA-approved device, the specific observational study design for GAVE outcomes is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Houston, Texas
- Memorial Hermann Hospital — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Nirav Thosani, MD MHA — The University of Texas Health Science Center, Houston
- Study coordinator: Prithvi B Patil, MS
- Email: prithvi.b.patil@uth.tmc.edu
- Phone: 713-500-6654
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.