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

Bleeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01328067
• Other study ID #: UF034
• Status: Withdrawn
• Phase: N/A
• Start date: June 2011
• Est. completion date: June 2017

Study information

• Verified date: June 2018
• Source: InSightec
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Bleeding
• Leiomyoma
• Pelvic Pain
• Uterine Fibroids

Intervention

Device:
• Exablate 2100
MRgFUS

Procedure:
• Myomectomy
Non-Hysteroscopic Myomectomy

Locations

Country	Name	City	State
United Kingdom	St. Mary's Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
InSightec

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	36 months post treatment
Primary	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).	36 months post treatment
Secondary	Efficacy	Post treatment change in patient's quality of life; Post treatment change in pelvic pain; Post treatment Change in bleeding; Post treatment recovery time	36 months post treatment

External Links

•   Sponsor's website