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Embolization of the Splenic Artery After Trauma

NCT05128955 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2025-04-24

No results posted yet for this study

Summary

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.

Conditions

  • High-grade Splenic Injuries

Interventions

DEVICE

Splenic artery embolization with vascular embolic coils or plugs

Splenic artery embolization with vascular embolic coils or plugs

Sponsors & Collaborators

  • Penumbra Inc.

    collaborator INDUSTRY

  • Andrew J. Gunn

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-10
Primary Completion
2026-12-31
Completion
2026-12-31
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 NCT05128955 on ClinicalTrials.gov