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Splenic Embolization for Portal Hypertension

NCT03532750 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2022-03-31

No results posted yet for this study

Summary

The primary purpose of this study is to evaluate the safety and efficacy of partial splenic artery embolization in the treatment of symptomatic portal vein hypertension. A secondary aim is to evaluate the relative efficacy of two separate splenic artery embolization techniques, coiling versus particle embolization of the spleen. These two methods will be compared to standard medical management which consist of pain management and fluid draining.

Conditions

  • Portal Hypertension

Interventions

DEVICE

Particle

1. 300-500 µm Embosphere Particles, Merit Medical (Rockland, MA) 501(k) number K991549. 2. 300-500 µm Embozene Particles, Boston Scientific (Marlborough, MA) 501(k) number K133447. 3. Ruby detachable coils, Penumbra (Alameda, CA) 501(K) number K103305. 4. Interlock detachable coils, Boston Scientific (Marlborough, MA) 501(k) number K132578.

DEVICE

Coil

Ruby or Interlock detachable coils

Sponsors & Collaborators

Principal Investigators

  • Shamar Young, MD · University of Minnesota

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-01
Primary Completion
2021-07-01
Completion
2021-07-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT03532750 on ClinicalTrials.gov