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

InSightec

Status: Withdrawn

Conditions: Uterine Fibroids; Pelvic Pain; Bleeding

Treatments: Device: Exablate 2100; Procedure: Myomectomy

Study type: Interventional

Funder types: Industry

Identifiers

NCT01328067

UF034

Details and patient eligibility

About

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.

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Treatment

Active Comparator group

Description:

MR guided Focused Ultrasound

Treatment:

Device: Exablate 2100

Surgery

Active Comparator group

Description:

Myomectomy

Treatment:

Procedure: Myomectomy