Clinical trial · Interventional
Comparison Study in the Treatment of Uterine Fibroids Uterine Fibroid Embolization Using BeadBlock™ Embolic Agent
Feasibility Evaluation of the Embolic Agent BeadBlock™ in the Treatment of Uterine Fibroids With Uterine Artery Embolization With Comparison of Study Endpoints to Embosphere®
NCT00361036CI-TRIAL-00004696completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leiomyoma | Leiomyoma | ONTOLOGY_EXACT | 0.98 |
| Leiomyomatosis | Leiomyomatosis | ONTOLOGY_EXACT | 0.98 |
| Uterine Neoplasms | Uterine Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Uterine fibroid embolization BeadBlock™ | Device | — | UNRESOLVED |
| Uterine fibroid embolization Embosphere® | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- BeadBlock treatment arm
- interventionNames
- Device: Uterine fibroid embolization BeadBlock™
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- Embospheres control arm
- interventionNames
- Device: Uterine fibroid embolization Embosphere®
Primary outcomes (1)
- measure
- 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
- timeFrame
- 12 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 50 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDWorthington-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 21127866