NCT00361036

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2006

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 3, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 7, 2006

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

April 18, 2011

Status Verified

April 1, 2011

Enrollment Period

3.6 years

First QC Date

August 3, 2006

Last Update Submit

April 14, 2011

Conditions

LeiomyomaLeiomyomatosisUterine Neoplasms

Keywords

LeiomyomaLeiomyomatosisUterine NeoplasmsBeadBlockEmbsophereEmbolizationUterine fibroid embolization

Outcome Measures

Primary Outcomes (1)

  • Change in fibroid devascularization as seen at contrast enhanced MRI performed several days after UAE and 3 months following the UAE between BeadBlock™ and Embosphere

    12 months

Secondary Outcomes (2)

  • Mean difference of change in fibroid devascularization CEMRI performed several days after UAE and 6 months following the UAE between BeadBlock™ and Embosphere.

    12 months

  • assess the change from baseline in symptom severity (UFS-QOL)at 3, 6 and 12 months (+/- 15 days) follow-up

    12 months

Study Arms (2)

1

EXPERIMENTAL

BeadBlock treatment arm

Device: Uterine fibroid embolization BeadBlock™

2

ACTIVE COMPARATOR

Embospheres control arm

Device: Uterine fibroid embolization Embosphere®

Interventions

Uterine fibroid embolization BeadBlock™DEVICE

Intervention with BeadBlock Microspehere

1
Uterine fibroid embolization Embosphere®DEVICE

Embosphere - control arm

2

Eligibility Criteria

Age30 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Albany Medical Center

Albany, New York, 12208, United States

Location

Image Guided Surgery Associates

Pottstown, Pennsylvania, 19464, United States

Location

Related Publications (1)

  • Worthington-Kirsch RL, Siskin GP, Hegener P, Chesnick R. Comparison of the efficacy of the embolic agents acrylamido polyvinyl alcohol microspheres and tris-acryl gelatin microspheres for uterine artery embolization for leiomyomas: a prospective randomized controlled trial. Cardiovasc Intervent Radiol. 2011 Jun;34(3):493-501. doi: 10.1007/s00270-010-0049-y. Epub 2010 Dec 3.

    PMID: 21127866DERIVED

Related Links

MeSH Terms

Conditions

LeiomyomaLeiomyomatosisUterine Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Robert Worthington-Kirsch, MD

    Image Guided Surgery Associates

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDIV

Study Record Dates

First Submitted

August 3, 2006

First Posted

August 7, 2006

Study Start

August 1, 2006

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

April 18, 2011

Record last verified: 2011-04

Locations

US(2)