NCT01328067

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

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: InSightec · Industry
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Uterine Fibroids
• Bleeding
• Pelvic Pain

Interventions

Type	Name	Description
DEVICE	Exablate 2100	MRgFUS
PROCEDURE	Myomectomy	Non-Hysteroscopic Myomectomy

Timeline

• Start date: 2011-06-01
• Primary completion: 2017-01-01
• Completion: 2017-06-01
• First posted: 2011-04-04
• Last updated: 2018-06-15

Locations

1 site across 1 country: United Kingdom