Clinical trial · Interventional
Magnetic Resonance (MR) Guided Focused Ultrasound Surgery of Uterine Fibroids
Post Approval Study: MR Guided Focused Ultrasound Surgery in the Treatment of Uterine Fibroids
- 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 goal of this study is to develop additional long term data to evaluate the safety and effectiveness of this treatment. Indications for use for this system is: 'The ExAblate is intended to ablate uterine fibroid tissue in pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure. Patients must have a uterine size of less than 24 weeks and not seeking treatment for reasons of improving fertility.'
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 |
|---|---|---|---|
| Leiomyoma | Leiomyoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ExAblate 2000 | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ExAblate MRgFUS
- description
- Treatment with the ExAblate 2000 system Version 4.1
- interventionNames
- Device: ExAblate 2000
Primary outcomes (1)
- measure
- Number and Type of Adverse Events
- timeFrame
- 36 months
- description
- Adverse events outcomes are reported in the adverse events module.
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * Women who present with symptomatic uterine fibroids and are not seeking treatment for the reason of improving fertility. * Able and willing to give consent and able to attend all study visits. * Patient is pre or peri-menopausal (within 12 months of last menstrual period). * Able to communicate sensations during the ExAblate procedure. * Uterine fibroids, which are device accessible (i.e., positioned in the uterus such that they can be accessed without being shielded by bowel or bone). * Fibroids(s) clearly visible on non-contrast magnetic resonance imaging (MRI). Exclusion Criteria: * Metallic implants that are incompatible with MRI * Sensitive to MRI contrast agents * Severe claustrophobia that would prevent completion of procedure in MR unit * Women who are pregnant or desire to become pregnant in the future. Pregnancies following ExAblate treatment could be dangerous for both mother and fetus. * Pedunculated fibroids * Active pelvic inflammatory disease (PID) * Active local or systemic infection * Known or suspected pelvic carcinoma or pre-malignant conditions, including sarcoma and adenomatous hyperplasia * Intrauterine device (IUD) anywhere in the treatment path * Dermoid cyst of the ovary anywhere in the treatment path * Extensive abdominal scarring that cannot be avoided by redirection of the beam (e.g., due to Caesarean section or repeated abdominal surgeries) * Undiagnosed vaginal bleeding
References
Publications (0)
Data not yet available