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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Bleeding; Uterine Fibroids
• Intervention / Treatment: Device: Exablate 2100

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Tours, France, 37044
    • Radiopharmaceutiques hopital Bretonneau
• Israel
  • Ramat Gan, Israel, 52621
    • Sheba MC
• Russian Federation
  • Moscow, Russian Federation
    • Research Centre of Obstetric / Gynaecology & Perinatology
• United Kingdom
  • London, United Kingdom, W2 1NY
    • St. Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 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 who are pregnant, as confirmed by serum/urine test at time of screening, or urine pregnancy test on the day of treatment
2. Uterine size > 24 weeks
3. Patients who are breast-feeding
4. Patients with active pelvic inflammatory disease (PID).
5. Patients with active local or systemic infection

6. Contraindication for MRI Scan:

   1. Severe claustrophobia that would prevent completion of procedure in the MR unit
   2. Weight greater than 250 IBS (113Kg)
   3. Implanted ferromagnetic materials and/or devices contraindicated for MR scan
   4. Known intolerance to MRI contrast agent (e.g. Gadolinium or Magnevist)
   5. Any other contraindication for MRI Scan
7. Extensive abdominal scarring in the beam path
8. Dermoid cyst obstructing the treatment path.
9. Known pelvic malignant or pre-malignant conditions
10. Intrauterine device (IUD) anywhere in the treatment path

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety	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.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Initial Efficacy	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	1 month

Collaborators and Investigators

• Sponsor: InSightec

Publications and helpful links

Helpful Links

• Sponsor's website

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: March 24, 2010
• First Submitted That Met QC Criteria: March 24, 2010
• First Posted (Estimate): March 25, 2010

Study Record Updates

• Last Update Posted (Estimate): February 22, 2012
• Last Update Submitted That Met QC Criteria: February 19, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: Pain; Quality of life; Bleeding; Uterine Fibroids; MR guided focused ultrasound
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Neoplasms, Connective Tissue; Neoplasms, Muscle Tissue; Hemorrhage; Leiomyoma; Myofibroma
• Other Study ID Numbers: UF032