An interventional study of Particle and Coil in Portal Hypertension, sponsored by University of Minnesota. Withdrawn at 1 site in United States. Open to participants aged 22 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-03-31.
Sponsored by University of Minnesota · Not applicable, Interventional, and Treatment
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.
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.
332 studies on the registry are indexed under Hypertension, Portal; 106 are open to participants now.
Browse Hypertension, Portal studies →University of Minnesota is the lead sponsor of 1,184 studies on the registry; 195 are open to participants now.
Of its 132 completed or terminated interventional studies of FDA-regulated products, 91 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients who are between 22-70 years of age.
Patients will need to meet one or more of the following requirements:
Exclusion Criteria:
This arm will undergo no study procedures and continue with best medical management. This entails managing pain and draining excess fluid.
Randomized to receive either the Embozene or Embosphere particles
Device: Particle
Randomized to receive either Ruby or Interlock detachable coils
Device: Coil
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.
Also known as: Embosphere Particles, Embozene Particles
Ruby or Interlock detachable coils
Also known as: Ruby Detachable Coils, Interlock Detachable Coils
Change in Quality of Life
Administration of the Chronic Liver Disease Questionnaire (CLDQ)
Time frame: pre-procedural (baseline) and at 1, 3, 6, and 12 month follow-up visits
Incidence of Treatment Adverse Events
Evaluation of all procedure-related adverse events (PRAE) and serious adverse events (SAE)
Time frame: Patients will be evaluated for adverse events post procedural at 72hrs, 1 week, and 1, 3, 6, and 12 months
Ascites Production
Fluid production
Time frame: pre-procedural and at 1, 3, and 6 months
Splenic Size
Changes in size of spleen as indicated by MRI or CT
Time frame: pre-procedural and at 1,3,6 and 12 months
Portal Vein Velocity
Changes in flow volume and velocity as evidenced by ultra sound
Time frame: pre-procedural and at 1, 6 and 12 months
Plan to share: No — All IPD generated for this study will only be reviewed by the study personnel who have been approved by the IRB. Any results that are shared, will be aggregate group data that does not address any individual participant directly.
No publications or documents are linked to this record.
This study is withdrawn, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Minnesota