Study to Evaluate the Safety and Effectiveness of MRgFUS Compared With Myomectomy for the Treatment of Uterine Fibroids

InSightec

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Uterine Fibroids Bleeding Pelvic Pain

Interventions

Exablate 2100DEVICE

MRgFUS

MyomectomyPROCEDURE

Non-Hysteroscopic Myomectomy

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

St. Mary's Hospital

London, United Kingdom

Outcomes

Primary Outcomes

Safety

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.

Time frame: 36 months post treatment

Efficacy

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).

Time frame: 36 months post treatment

Secondary Outcomes

Efficacy

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

Time frame: 36 months post treatment

Data from ClinicalTrials.gov

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