NCT03532750

Splenic Embolization for Portal Hypertension

Safety and Efficacy of Splenic Artery Embolization to Treat Symptomatic Portal

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Minnesota · Academic / Other
• Sex: All
• Age: 22 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a single center phase I/II study that is designed to assess the safety and efficacy of splenic artery embolization in the setting of symptomatic portal hypertension. All participating investigators have signed the protocol agreement and no investigator will be added until they sign the agreement. The study will not be initiated until FDA and IRB approval is obtained. The study will consist of a 4 week screening period, day of treatment, and 12-month follow-up period. 60 subjects will be enrolled, with a goal of randomizing 30, at the University of Minnesota Medical Center. Enrollment is expected to take up to 48 months. The collection of data will be accomplished by utilizing a clinical research team that will obtain symptomatic portal hypertension improvement and safety assessments. Efficacy assessments will include; change in portal vein velocity, ascitic fluid production change, reduction in splenic size, and improvement in quality of life (QoL). Safety assessments include subject and investigator reported adverse events, subjective pain, and splenic abscess formation.

Conditions

• Portal Hypertension

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-11-01
• Primary completion: 2021-07-01
• Completion: 2021-07-01
• First posted: 2018-05-22
• Last updated: 2022-03-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study