Clinical trial NCT01328067: Study to Evaluate the Safety and Effectiveness of MRgFUS Compared With Myomectomy for the Treatment of Uterine Fibroids
Official title: A Randomized Study to Evaluate the Safety and Effectiveness of MRgFUS Procedure Compared With Myomectomy for the Treatment of Uterine Fibroids
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Uterine Fibroids
Bleeding
Pelvic Pain
Keywords: MRgFus
Uterine Fibroids
Pelvic Pain
Quality of Life
Symptomatic Uterine Fibroids
Lead sponsor: InSightec
Sponsor class: INDUSTRY
First posted: 2011-04-04
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Safety
timeFrame: 36 months post treatment
measure: Efficacy
timeFrame: 36 months post treatment
Secondary outcomes:
measure: Efficacy
timeFrame: 36 months post treatment
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St. Mary's Hospital
Study officials:
affiliation: St Mary's Hospital, London
name: Wady Gedroyc, Prof.
role: PRINCIPAL_INVESTIGATOR
References: