Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00361036
Status:
COMPLETED
Last Update Posted:
2011-04-18
First Post:
2006-08-03
Brief Title:
Comparison Study in the Treatment of Uterine Fibroids Uterine Fibroid Embolization Using BeadBlock Embolic Agent
Sponsor:
Worthington-Kirsch Robert L MD
Organization:
Worthington-Kirsch Robert L MD
Study Overview
Official Title:
Feasibility Evaluation of the Embolic Agent BeadBlock in the Treatment of Uterine Fibroids With Uterine Artery Embolization With Comparison of Study Endpoints to Embosphere
Status:
COMPLETED
Status Verified Date:
2011-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A double arm non-inferiority 44 patient study to assess the performance of BeadBlock in the treatment of uterine fibroids by embolization with respect to clinical imaging outcome with comparison of primary safety endpoints to Embosphere
Detailed Description:
The purpose of the study is to conduct a comparison between BeadBlock and Embosphere in uterine fibroid embolization Baseline and follow-up MR Imaging data will be made with respect to changes in fibroid and uterus perfusion and fibroid and uterine volume This is a 12 months study 12 month follow up for all enrollees The primary end-point will be the degree of fibroid devascularization as seen at contrast-enhanced MRI performed 3 months - 15 days after UAE procedure In addition we will assess symptom reduction in patients that have undergone uterine fibroid embolization with Bead Block and Embosphere
Primary Objective 1 To assess the change in fibroid devascularization as seen at contrast-enhanced MRI performed after UAE and at three 3 months - 15 days following the UAE and compare the changes between BeadBlock and Embosphere
Secondary Objective
1 To assess the change in fibroid devascularization as seen at contrast-enhanced MRI performed several days after UAE and 6 months - 15 days following the UAE and compare the changes between BeadBlock and Embosphere
Tertiary Objective
1 To assess the change in uterine volume as seen at contrast-enhanced MRI performed several days after UAE 3 months - 15 days and 6 months - 15 days following the UAE and compare the changes between BeadBlock and Embosphere
2 To assess the change from baseline in symptom severity UFS-QOLat 3 6 and 12 months - 15 days follow-up as measured by the subscale of the UFS questionnaire and compare the changes between BeadBlock and Embosphere
Primary Objective 1 To assess the change in fibroid devascularization as seen at contrast-enhanced MRI performed after UAE and at three 3 months - 15 days following the UAE and compare the changes between BeadBlock and Embosphere
Secondary Objective
1 To assess the change in fibroid devascularization as seen at contrast-enhanced MRI performed several days after UAE and 6 months - 15 days following the UAE and compare the changes between BeadBlock and Embosphere
Tertiary Objective
1 To assess the change in uterine volume as seen at contrast-enhanced MRI performed several days after UAE 3 months - 15 days and 6 months - 15 days following the UAE and compare the changes between BeadBlock and Embosphere
2 To assess the change from baseline in symptom severity UFS-QOLat 3 6 and 12 months - 15 days follow-up as measured by the subscale of the UFS questionnaire and compare the changes between BeadBlock and Embosphere
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None