Clinical trial · Observational
Bearing nsPVA Embolization for Uterine Artery Embolization (BETTER-UAE)
Prospective, Multi-Center Study Using Bearing nsPVA Embolization Particles for the Treatment of uTErine fibRoids With Uterine Artery Embolization
NCT06153667CI-TRIAL-00112973BETTER-UAErecruitingClinicalTrials.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, multicenter, observational, post-market clinical follow-up study in subjects treated with Bearing nsPVA Embolization Particles for uterine fibroid embolization. Data collection will include safety and performance outcome relating to the use of Bearing nsPVA, through 6 months.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uterine Fibroid | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bearing nsPVA | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Primary Safety
- timeFrame
- 30 days
- description
- The primary safety endpoint will be the absence of serious device-related adverse events (AEs) through 30 days.
- measure
- Primary Effectiveness
- timeFrame
- 6 months
- description
- The primary effectiveness endpoint will be clinical success defined as ≥ 50% improvement in the Uterine Fibroid Symptom and Quality of Life (UFS-QoL) Symptom Severity subscale at 6 months as compared to baseline.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult women ≥ 18 years old at the time of enrollment. * Subject has symptomatic uterine fibroid(s), suitable to embolization. * Subject provides written informed consent. Exclusion Criteria: * Subject is pregnant. * Subject has suspected pelvic inflammatory disease or any other pelvic infection. * Subject has any malignancy of the pelvic region, (e.g., endometrial neoplasia).
References
Publications (0)
Data not yet available
No reference posted for this study.