Clinical trial · Interventional
OCL 500 Treatment of Women With Symptomatic Uterine Fibroids
An Open Label, Single Center Study to Evaluate the Safety and Effectiveness of OCL 500 Embolization Microspheres (OCL 500) in Uterine Artery Embolization for the Treatment of Premenopausal Women With Symptomatic Uterine Fibroids
NCT03427671CI-TRIAL-00040560completedN/AClinicalTrials.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)
This is a prospective, open-label, single-arm, safety and effectiveness study of Occlusin 500 microspheres in women with symptomatic uterine fibroids.
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 |
| Myoma | Myoma | ONTOLOGY_EXACT | 0.98 |
| Uterine Fibroid | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Occlusin 500 Microspheres | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Occlusin 500 microspheres
- description
- Uterine fibroid embolization
- interventionNames
- Device: Occlusin 500 Microspheres
Primary outcomes (1)
- measure
- Fibroid volume
- timeFrame
- 6 months post-embolization
- description
- Magnetic Resonance Imaging-determined fibroid volume
Secondary outcomes (5)
- measure
- Uterine volume
- timeFrame
- 1 month post-embolization
- description
- Magnetic Resonance Imaging-determined uterine volume
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * Premenopausal women with symptomatic uterine fibroids * Willing and able to provide informed consent * Fibroids visible by ultrasound or non-contrast magnetic resonance imaging * Fibroids with a minimum diameter of 4cm for a single fibroid or 3cm where there are 2 or more fibroids; minimum total fibroid burden 33cc * Documented ovulation by Luteinizing Hormone (LH) testing * Follicle Stimulating Hormone (FSH) value \>40 IU/L within 3 months prior to procedure * Pelvic examination within 6 months prior to procedure * Normal Pap smear Exclusion Criteria: * Positive pregnancy test * Uterine size \> 20 weeks gestation * Fibroids that are more than 50% submucosal * Individual fibroids \> 12cm in diameter, or total fibroid burden \> 905cc * Pedunculated subserosal fibroids with an attachment to the uterus less than 50% of the greatest diameter of the fibroid * Fibroids situated in the cervix * Abnormally large ovarian arteries * Uterine pathology other than fibroids * History of gynecologic malignancy * Active pelvic infection or history of pelvic inflammatory disease * Undiagnosed pelvic mass outside the uterus * History of chemotherapy or radiation to the abdomen or pelvis * Intra-Uterine Device (IUD) in position * History of, or ongoing, hemolytic anemia * Severe cerebrovascular disease defined by a cerebrovascular accident within 6 months of treatment * Anticoagulant therapy or known bleeding disorder * Treatment with Gonadotropin Releasing Hormone (GnRH) agonists within the previous 6 weeks * Received another investigational agent within past 12 weeks * Compromised hematopoietic function * Compromised hepatic function * Compromised renal function * BMI \> 38 * Claustrophobia * Contraindication to angiography * Contraindication to magnetic resonance imaging (MRI) or MRI contrast agents * Allergy to contrast agents * Allergy to bovine collagen * Patient desires to become pregnant, or does not agree to contraception during study
References
Publications (0)
Data not yet available
No reference posted for this study.