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Embolization in Splenic Trauma

NCT03613454 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2021-08-11

Study results available
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Summary

Randomized, prospective, feasibility study to begin evaluating the efficacy, safety, and cost of using either coils or vascular plugs (VPs) for proximal splenic artery embolization in the setting of traumatic splenic injury.

Conditions

  • Trauma to the Spleen

Interventions

DEVICE

Splenic artery embolization with vascular embolic coils

Splenic artery embolization with vascular embolic coils

DEVICE

Splenic artery embolization with vascular embolic plugs

Splenic artery embolization with vascular embolic plugs

Sponsors & Collaborators

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Andrew J Gunn, MD · The University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-16
Primary Completion
2020-03-03
Completion
2021-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03613454 on ClinicalTrials.gov