Comparison Study in the Treatment of Uterine Fibroids Uterine Fibroid Embolization Using BeadBlock™ Embolic Agent

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2010-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Embozene Microspheres for Uterine Fibroid Embolization (UFE)

NCT01675011

Uterine Fibroids

TERMINATED NA

Safety and Efficacy of Embozene Microspheres for Uterine Fibroid Embolization

NCT02884960

Uterine Fibroids

UNKNOWN NA

Bearing nsPVA Embolization for Uterine Artery Embolization (BETTER-UAE)

NCT06153667

Uterine Fibroid

RECRUITING

Uterine Fibroid Embolization- Long Term Follow up and Technical Perspectives

NCT01852734

Uterine Fibroids Arterial Embolization

COMPLETED NA

Uterine Artery Embolization With Microspheres in Patients With Leiomyoma.

NCT03535610

Uterine Leiomyoma

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Leiomyoma Leiomyomatosis Uterine Neoplasms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

BeadBlock treatment arm

Group Type EXPERIMENTAL

Uterine fibroid embolization BeadBlock™

Intervention Type DEVICE

Intervention with BeadBlock Microspehere

2

Embospheres control arm

Group Type ACTIVE_COMPARATOR

Uterine fibroid embolization Embosphere®

Intervention Type DEVICE

Embosphere - control arm

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Uterine fibroid embolization BeadBlock™

Intervention with BeadBlock Microspehere

Intervention Type DEVICE

Uterine fibroid embolization Embosphere®

Embosphere - control arm

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Patient chooses to participate and has signed informed consent
2. Age between 30 and 50 years old
3. Symptoms caused by uterine fibroids, such as heavy bleeding (menorrhagia) and/or bulk-related complaints such as urinary frequency, constipation or pelvic pain.
4. Patient has fibroids confirmed by MRI
5. Patient has normal kidney function.
6. Patient is willing and able to undergo follow-up imaging at 3 and 6 months post UFE.

Exclusion Criteria

1. Patients who are pregnant or plan to become pregnant within the study period, or desire future fertility.
2. Patients with a history of gynecologic malignancy
3. Patients with known endometrial hyperplasia
4. Patients with adenomyosis
5. Patients with pelvic inflammatory disease
6. Patients with Uteri \< 250 ml (cm) calculated volume or \> 24 weeks
7. Patients with pedunculated subserosal fibroids with a narrow attachment (\<50% diameter of the fibroid) to the uterus.
8. Patients with pelvic pain as dominant syndrome
9. Known allergy to contrast media that cannot be adequately pre-medicated.
10. Patients not suitable for arterial access.
11. Previous uterine artery embolization attempts.
12. History of pelvic irradiation.
13. Patients on GnRH Therapy within 3-6 months prior to the study enrollment.

Minimum Eligible Age

30 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No