Clinical trial · Interventional
MR Guided Focused Ultrasound Surgery in the Treatment of Uterine Fibroids
Post Approval Study: MR Guided Focused Ultrasound Surgery in the Treatment of Uterine Fibroids
NCT00166270CI-TRIAL-00033682completedN/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, nonrandomized, multi-center study to evaluate the safety and effectiveness of ExAblate in the treatment of uterine fibroids. All patients will be treated and then followed for 36 months to evaluate the change in their fibroid symptoms.
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 Fibroids | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ExAblate 2000 | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Device: ExAblate 2000
Primary outcomes (1)
- measure
- Measures of the clinical success of patients who elect treatment of fibroids are generally subjective, and evaluated by the patient in terms of improvement.
- timeFrame
- Within 1 month of Treatment
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
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 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 * 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
No reference posted for this study.