Embolization of the Splenic Artery After Trauma
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- Andrew J. Gunn
- Study ID
- NCT05128955
- Status
- Recruiting
Conditions
- High-grade Splenic Injuries
Eligibility Criteria
- Sex
- ALL
- Age
- 15 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Splenic artery embolization with vascular embolic coils or plugs — DEVICESplenic artery embolization with vascular embolic coils or plugs
Study Details
Our aim is to conduct a multi-center, Bayesian, randomized clinical trial to evaluate the primary technical success of coils and vascular plugs for proximal splenic artery embolization in the setting of high-grade splenic trauma. The investigator has previously demonstrated the feasibility of such a study in a single center pilot trial.
Key Dates
- Start date
- May 10, 2022
- Status verified
- Apr 2025
- Primary completion
- Dec 31, 2026
- Completion
- Dec 31, 2026
Study Design
- Enrollment
- 250 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Active Comparator: Splenic artery embolization with vascular embolic coilsDevice: Splenic artery embolization with vascular embolic coils
- Active Comparator: Active Comparator: Splenic artery embolization with vascular embolic plugsActive Comparator: Splenic artery embolization with vascular embolic plugs
Primary Outcome Measure
Primary Technical Success [ Time Frame: 3 years ]
Central Contacts
- April Riddle, BS2059346504
- Evan Hudson, BS2059346499
Locations (5)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | Theresa Caridi, MD (PRINCIPAL_INVESTIGATOR) |
| Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | 27157 | Heather Hilton Michael Miller, MD, FSIR (PRINCIPAL_INVESTIGATOR) Raisa Durrani, MD (SUB_INVESTIGATOR) |
| Ohio State University Medical Center | Columbus | Ohio | 43210 | Tammi Stein Mina Makary, MD (PRINCIPAL_INVESTIGATOR) Carrie Sims, MD (SUB_INVESTIGATOR) Henry Wang, MD, MPH, MS (SUB_INVESTIGATOR) |
| Prisma Health | Greenville | South Carolina | 29615 | Ashley Susan Mike Devane, MD (PRINCIPAL_INVESTIGATOR) |
| The University of Texas Health Science Center at Houston McGovern Medical School | Houston | Texas | 77030 | Ahmed Aal, MD, PhD (PRINCIPAL_INVESTIGATOR) |