Clinical trial · Interventional
Study to Evaluate the Safety and Effectiveness of MRgFUS Compared With Myomectomy for the Treatment of Uterine Fibroids
A Randomized Study to Evaluate the Safety and Effectiveness of MRgFUS Procedure Compared With Myomectomy for 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 objective of this trial is to evaluate the safety and efficacy of ExAblate for the treatment of uterine fibroids. Women, seeking treatment for symptomatic uterine leiomyomata will be eligible for the study.Women who agree to participate will sign an informed consent and will be randomized to ExAblate treatment or myomectomy. All patients will be followed through the 36 month visit. Follow-up visits/telephone calls will be completed at 1 week, 2 weeks, 6 weeks, 3 months, 6, 12, 18, 24 and 36 months post treatment. Patients will be evaluated by assessing their overall physical and mental health as well as for device/procedure related adverse events.
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 |
|---|---|---|---|
| Bleeding | — | UNRESOLVED | — |
| Pelvic Pain | — | UNRESOLVED | — |
| Uterine Fibroids | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exablate 2100 | Device | — | UNRESOLVED |
| Myomectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Treatment
- description
- MR guided Focused Ultrasound
- interventionNames
- Device: Exablate 2100
- type
- ACTIVE_COMPARATOR
- label
- Surgery
- description
- Myomectomy
- interventionNames
- Procedure: Myomectomy
Primary outcomes (2)
- measure
- Safety
- timeFrame
- 36 months post treatment
- description
- Safety will be evaluated by recording and assessing the incidence and severity of major adverse events from treatment through the 3 years follow-up period.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: 1. Women age 18 or older 2. Symptomatic uterine fibroids, defined as those resulting in scores of 21 or higher, based on patient responses to questions 1-8 (raw score) of the Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL). 3. Women who have given written informed consent 4. Women who are able and willing to attend all study visits 5. Patient is pre or peri-menopausal (within 12 months of last menstrual period) 6. Able to communicate sensations during the ExAblate procedure 7. Uterine fibroids, which are device accessible 8. Fibroid(s) clearly visible on non-contrast MRI. 9. Fibroid(s) enhances on MR contrast imaging Exclusion Criteria: 1. Women currently pregnant 2. Uterine size \> 24 cm W/O the cervix 3. More than 4 clinically significant fibroids (per MRI) 4. Prior myomectomy, UAE 5. Allergy to either gadolinium or iodinated contrast 6. Implanted metallic device prohibiting MRI 7. Severe claustrophobia 8. Active pelvic infection 9. Current use of intrauterine contraceptive device 10. Unstable medical conditions requiring additional monitoring during the procedure 11. Bleeding diathesis requiring medical treatment 12. Imaging suggestive of malignant disease of uterus, ovary, or cervix 13. Imaging and suggestive of adenomyosis. 14. Pedunculated submucosal or pedunculated subserosal myoma 15. Size and weight which prohibits subject from fitting in MRI device 16. Unavoidable, scarring, skin folds or irregularity, bowel, pubic bone, IUD, surgical clips or hard implants in the beam path. 17. Hyper intense fibroid relatively to the uterus muscle 18. Women with ovarian dermoid cyst anywhere in the treatment path
References
Publications (0)
Data not yet available