A Clinical Study to Evaluate Safety of the ExAblate 2100 UF V2 System in the Treatment of Symptomatic Uterine Fibroids

Sponsor

InSightec (Industry)

Overall Status

Completed

CT.gov ID

NCT01092988

Collaborator

(none)

Enrollment

Locations

Arm

23.1

Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The first magnetic resonance-guided focused ultrasound (MRgFUS) treatment of uterine fibroid using the ExAblate 2000 system was performed in 2001. Since then, more than 5000 treatments were done in more than 60 different hospitals around the world. The experience accumulated in this novel treatment was collected by InSightec and implemented into software and hardware updates, clinical tips and guidelines, all aimed to improve the clinical results and their durability, while maintaining a high level of safety.

Based on extensive clinical experience and our internal research and development effort goals toward continuous improvement in ExAblate treatment safety and performance, limited changes have been made to the current ExAblate system. This modified ExAblate system version is designated as the ExAblate 2100 UF V2 system.

The modifications are believed to improve system's friendliness to the user, without introducing new risks or other issues of safety of the device, and should not have any negative impact on the safety or technical efficacy of the treatments for patients.

Condition or Disease	Intervention/Treatment	Phase
Uterine Fibroids Bleeding Pain	Device: Exablate 2100	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Clinical Study to Evaluate Safety of the ExAblate 2100 UF V2 System in the Treatment of Symptomatic Uterine Fibroids

Study Start Date :

Mar 1, 2010

Actual Primary Completion Date :

Feb 1, 2012

Actual Study Completion Date :

Feb 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Exablate 2100 MR Guided Focused Ultrasound treatment	Device: Exablate 2100 MR guided focused ultrasound

Arm

Intervention/Treatment

Experimental: Exablate 2100

MR Guided Focused Ultrasound treatment

Device: Exablate 2100

MR guided focused ultrasound

Outcome Measures

Primary Outcome Measures

Safety [1 month]
Safety of ExAblate 2100 UF V2 will be determined by an evaluation of the incidence and severity of device- and procedure-related adverse events from the first visit through 1-month post-treatment.

Secondary Outcome Measures

Initial Efficacy [1 month]
Efficacy will be evaluated by comparing the Non-perfused volume obtained from this study with that of the dataset supporting PMA approval using descriptive statistics

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Women age 18 or older
Symptomatic uterine fibroids, defined as those resulting in scores of 21 or higher, based on patient responses to questions 1-8 of the Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL).
Women who have given written informed consent
Women who are able and willing to attend all study visits
Patient is pre or peri-menopausal (within 12 months of last menstrual period)
Able to communicate sensations during the ExAblate procedure.
Uterine fibroids, which are device accessible
Fibroid(s) clearly visible on non-contrast MRI.
Fibroid(s) enhances on MR contrast imaging

Exclusion Criteria:

Women who are pregnant, as confirmed by serum/urine test at time of screening, or urine pregnancy test on the day of treatment
Uterine size > 24 weeks
Patients who are breast-feeding
Patients with active pelvic inflammatory disease (PID).
Patients with active local or systemic infection
Contraindication for MRI Scan:
Severe claustrophobia that would prevent completion of procedure in the MR unit
Weight greater than 250 IBS (113Kg)
Implanted ferromagnetic materials and/or devices contraindicated for MR scan
Known intolerance to MRI contrast agent (e.g. Gadolinium or Magnevist)
Any other contraindication for MRI Scan
Extensive abdominal scarring in the beam path
Dermoid cyst obstructing the treatment path.
Known pelvic malignant or pre-malignant conditions
Intrauterine device (IUD) anywhere in the treatment path

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Radiopharmaceutiques hopital Bretonneau	Tours	France	37044
2	Sheba MC	Ramat Gan	Israel	52621
3	Research Centre of Obstetric / Gynaecology & Perinatology	Moscow	Russian Federation
4	St. Mary's Hospital	London	United Kingdom	W2 1NY