Bleeding, Pelvic Pain, Uterine Fibroids
Conditions
Keywords
MRgFus, Uterine Fibroids, Pelvic Pain, Quality of Life, Symptomatic Uterine Fibroids
Brief summary
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.
Interventions
DEVICEExablate 2100
MRgFUS
PROCEDUREMyomectomy
Non-Hysteroscopic Myomectomy
Sponsors
InSightec
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety | 36 months post treatment | 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. |
| Efficacy | 36 months post treatment | Comparison between ExAblate treatment and non-Hysteroscopic Myomectomy in terms of treated patients who did not undergo another interventional treatment for recurrence of uterine fibroid symptoms at up to 36 months (3 years). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy | 36 months post treatment | 1. Post treatment change in patient's quality of life 2. Post treatment change in pelvic pain 3. Post treatment Change in bleeding 4. Post treatment recovery time |
Countries
United Kingdom
Outcome results
None listed