Clinical trial · Interventional
MR Guided Focused Ultrasound Treatment of Uterine Fibroids With Enhanced Sonication
A Clinical Study To Evaluate the Safety and Efficacy of MR Guided Focused Ultrasound Treatment of Uterine Fibroids With Enhanced Sonication Techniques
NCT00365989CI-TRIAL-00036954completedPhase 3Results postedClinicalTrials.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 phase 3 study to determine the safety of the new features to the FDA approved ExAblate device using a new method to ablate fibroids deemed Enhanced Sonication.
Conditions
Conditions (2)
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 |
| Uterine Leiomyoma | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ExAblate Enhanced Sonication | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ExAblate Enhanced Sonication Test Arm
- description
- The intervention to be administered is ExAblate Enhanced Sonication. The purpose of this study is to examine the safety profile of the ExAblate Enhanced Sonication mode to insure that no new safety issues are introduced compared to the normal focused ultrasound mode.
- interventionNames
- Device: ExAblate Enhanced Sonication
Primary outcomes (1)
- measure
- Number of Adverse Events
- timeFrame
- Within 1 month of treatment
- description
- The study objective is to determine the safety of the new Enhanced Sonication technique and assure no new safety issues are introduced.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Women age 18 or older, who present with symptomatic fibroids 2. Women who have given written informed consent 3. Women who are able and willing to attend all study visits. 4. Patient is pre or peri-menopausal (within 12 months of last menstrual period). 5. Able to communicate sensations during the ExAblate procedure. 6. 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). 7. Fibroids(s) clearly visible on non-contrast MRI. Exclusion Criteria: 1. Women who are pregnant, as confirmed by serum test at time of screening, or urine pregnancy test on the day of treatment 2. Patient who desire to become pregnant in the future. 3. Patients who are breast-feeding. 4. Patients with an active pelvic inflammatory disease (PID) 5. Active local or systemic infection 6. Metallic implants that are incompatible with MRI 7. Known intolerance to the MRI contrast agent (e.g. Gadolinium or Magnevist) 8. Severe claustrophobia that would prevent completion of procedure in the MR unit. 9. Extensive abdominal scarring in the beam pass or dermoid cyst of the ovary anywhere in the treatment path. 10. Known or suspected pelvic carcinoma or pre-malignant conditions, including sarcoma and adenomatous hyperplasia. 11. Pedunculated fibroids. 12. Intrauterine device (IUD) anywhere in the treatment path 13. Undiagnosed vaginal bleeding.
References
Publications (0)
Data not yet available
No reference posted for this study.