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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01092988
• Other study ID #: UF032
• Status: Completed
• Phase: N/A
• First received: March 24, 2010
• Last updated: February 19, 2012
• Start date: March 2010
• Est. completion date: February 2012

Study information

• Verified date: February 2012
• Source: InSightec
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

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 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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bleeding
• Leiomyoma
• Pain
• Uterine Fibroids

Intervention

Device:
• Exablate 2100
MR guided focused ultrasound

Locations

Country	Name	City	State
France	Radiopharmaceutiques hopital Bretonneau	Tours
Israel	Sheba MC	Ramat Gan
Russian Federation	Research Centre of Obstetric / Gynaecology & Perinatology	Moscow
United Kingdom	St. Mary's Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
InSightec

Countries where clinical trial is conducted

France,  Israel,  Russian Federation,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No

External Links

•   Sponsor's website