Clinical trial · Interventional
Uterine Fibroid Embolization (UFE) for Symptomatic Fibroids: Comparison of Gel-Bead to Commonly Used Embolic Agents.
NCT03072446CI-TRIAL-00038543completedN/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)
The purpose of this post-market study is to evaluate UFE agents for the treatment of symptomatic uterine fibroids, using Gel-Bead compared to four other commonly used embolic agents.
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 |
|---|---|---|---|
| Embolization | — | UNRESOLVED | — |
| Symptoms | — | UNRESOLVED | — |
| Uterine Fibroid | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gel-Beads embolic material | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gel-Beads arm
- description
- This group will undergo embolization of symptomatic uterine fibroids with Gel-Beads embolic agent
- interventionNames
- Device: Gel-Beads embolic material
Primary outcomes (2)
- measure
- Degree of Fibroid Tissue Infarction at 3 months
- timeFrame
- 3 months
- description
- The primary endpoint is the degree of fibroid tissue infarction at 3 months post-procedure. Results for the total fibroid load and the dominant fibroid will be categorized as either 100% (Group A) ≥ 90-99% (Group B) or \<90% (Group C) infarcted. The degree of infarction will be visually estimated by the investigator.
- measure
- Characterization of adverse events over 3 months
- timeFrame
- 3 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Female, age 18 years or older 2. Symptomatic uterine fibroid(s) requiring treatment per the investigators assessment 3. Negative serum pregnancy test at the Baseline visit and practicing effective contraception during the study 4. Willing to provide written informed consent prior to initiation of study procedures 5. Willing to comply with the specified study assessments and follow-up requirements Exclusion Criteria: 1. Known hypersensitivity to porcine products or intravascular contrast material 2. Vascular anatomy or blood flow precluding correct catheter placement or embolic injection 3. Presence of collateral vessel pathways potentially endangering normal territories during embolization
References
Publications (0)
Data not yet available
No reference posted for this study.