Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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-QOL)at 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00361036
Study type Interventional
Source Worthington-Kirsch, Robert L., M.D.
Contact
Status Completed
Phase Phase 1
Start date August 2006
Completion date March 2010

See also
  Status Clinical Trial Phase
Recruiting NCT04172272 - The Influence of TAP Block in the Control of Postoperative Pain After Laparotomy for Gynecological Procedures N/A
Terminated NCT02940041 - Concordance Between Sonography Amd MRI for Presurgical Diagnosis of Uterine Mesenchymal Malignant Tumors
Withdrawn NCT00768742 - Safety and Effectiveness Study of RF Ablation of Uterine Fibroids to Reduce Menstrual Bleeding: the Fibroid Ablation Study N/A
Completed NCT00156195 - Study to Evaluate the Safety of Asoprisnil in the Treatment of Uterine Fibroids Phase 3
Completed NCT00152256 - A Study to Evaluate of the Safety and Effectiveness of Asoprisnil in Treating Women With Uterine Fibroids Phase 3
Completed NCT00160381 - A Study to Evaluate the Safety and Effectiveness of Asoprisnil in the Treatment of Uterine Fibroids Phase 3
Recruiting NCT04214457 - Development of a Predictive Model for Early Differential Diagnosis of Uterine Leiomyomas and Leiomyosarcomas
Completed NCT00044876 - Treatment of Uterine Fibroids With CDB-2914, an Experimental Selective Progesterone Receptor Antagonist Phase 2
Completed NCT02889848 - Safety and Tolerability of Collagenase Clostridium Histolyticum (EN3835) to Treat Uterine Leiomyoma (Fibroids) Phase 1
Recruiting NCT04145518 - Mechanistic Characterization of Uterine Pain Phase 4
Completed NCT01816815 - Study in Healthy Tubal Ligated Women to Evaluate Pharmacodynamics, Safety and Pharmacokinetics of BAY1002670 Phase 1
Completed NCT00891657 - Post Market Study for an Adhesion Barrier Following Laparoscopic Myomectomy N/A
Completed NCT00156156 - Study of Asoprisnil in the Treatment of Uterine Fibroids. Phase 3
Recruiting NCT05538689 - Surgical Myomectomy Followed by Oral Myfembree Versus Standard of Care Trial (SOUL) Phase 4
Active, not recruiting NCT03323905 - Single Arm Study Using the Symphony -- MRI Guided Focused Ultrasound System for the Treatment of Leiomyomas N/A
Terminated NCT03342859 - Mode of Action Study of Vilaprisan and Ulipristal Acetate in Patients With Uterine Fibroids for Whom Surgery is Planned Phase 1
Recruiting NCT06135870 - Role of Senescent Cells in Uterine Fibroid Pathogenesis (SOUL Study)
Completed NCT02777203 - Power Morcellation Systems for Laparoscopic Hysterectomy and Myomectomy N/A
Completed NCT02189083 - Study of Tumor-shrinking Decoction (TSD) to Treat Symptomatic Uterine Fibroids Phase 3
Completed NCT01123603 - Lower Urinary Tract Infection (UTI) Evaluation in Women With Uterine Leiomyomata N/A