Battle of the devices: which tool best mends a broken spleen?
NCT ID NCT05128955
First seen Jun 29, 2026 · Last updated Jun 30, 2026 · Updated 1 time
Summary
This trial compares two medical devices—coils and plugs—used to block blood flow in the splenic artery after a severe spleen injury (grade III or higher). The goal is to see which device works faster and more reliably to stop bleeding without surgery. About 180 people aged 15 and older with such injuries will be randomly assigned to receive one of the two devices during a minimally invasive procedure.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Splenic artery embolization with vascular embolic coils or plugs
- What this could lead to
- If successful, this could identify the best device for stopping bleeding from severe spleen injuries without surgery, potentially improving outcomes and reducing complications.
- What could go wrong
- This is a mid-stage trial with 180 participants, so results may not apply to all patients. The study focuses on technical success, not long-term recovery, and device failure or complications are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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180 people
The number who actually took part.
- Started
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May 2022
- Finished
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Apr 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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15 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. ≥15 years of age 2. Trauma resulting in grade III or higher splenic injury on contrast-enhanced CT 3. Splenic injury to be treated by non-operative management as decided by attending trauma surgeon and interventional radiologist 4. The attending interventional radiologist determines that the patient will undergo proximal splenic artery embolization with the specific method to be decided by randomization. Exclusion Criteria: 1. Inability to obtain informed consent 2. ≤ 50kg 3. Uncorrectable coagulopathy 4. Patient is immunocompromised 5. Pregnant 6. Breast-feeding 7. Non-English speakers 8. Prisoners
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Ohio State University Medical Center
Columbus, Ohio, 43210, United States
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Prisma Health
Greenville, South Carolina, 29615, United States
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The University of Texas Health Science Center at Houston McGovern Medical School
Houston, Texas, 77030, United States
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University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
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Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157, United States