Clinical trial · Interventional
Uterine Artery Embolization With Microspheres in Patients With Leiomyoma.
NCT03535610CI-TRIAL-00046990EMBOSOFT IcompletedN/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)
To evaluate the therapeutic response to uterine artery embolization in 30 patients with leiomyoma using the microspheres Embosoft (Embosoft® - Scitech Medical).
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 Leiomyoma | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Uterine Embolization | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Embolization
- description
- Uterine Embolization with PVA Microspheres
- interventionNames
- Device: Uterine Embolization
Primary outcomes (2)
- measure
- Uterine Volume Reduction
- timeFrame
- 6 months
- description
- Uterine Volume Reduction measured by MRI
- measure
- Fibroid Reduction
- timeFrame
- 6 months
- description
- Fibroid Reduction measured by MRI
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * female patients from 18 to 50 years old; * symptomatic uterine intramural leiomyomas or multiple symptomatic leiomyomas in the presence of intramural; * patient agrees with study procedures; * patient signs the informed consent form. Exclusion Criteria: * asymptomatic women; * isolated adenomyosis, pediculated subserous myoma, submucous leiomyoma (50% of uterine cavity diameter), intraligamentous leiomyoma; * leiomyoma diameter higher than 10 cm; * leiomyoma above the umbilical scar; * endometrial neoplasia or hyperplasia or presence of any malignancy * pregnant or breast feeding women; * active vasculitis; * pelvic irradiation history; * uncontrolled coagulopathies; * renal insufficiency; * contrast allergy; * concomitant use of GnRH analogues.
References
Publications (0)
Data not yet available
No reference posted for this study.