Ignite Creation Date:
2024-05-06 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 12:46 PM
Study NCT ID:
NCT03532750
Status:
WITHDRAWN
Last Update Posted:
2022-03-31
First Post:
2018-04-25
Brief Title:
Splenic Embolization for Portal Hypertension
Sponsor:
University of Minnesota
Organization:
University of Minnesota
Study Overview
Official Title:
Safety and Efficacy of Splenic Artery Embolization to Treat Symptomatic Portal
Status:
WITHDRAWN
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI left institution
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 III 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None