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

This study has been completed.
Sponsor:
Information provided by:
InSightec
ClinicalTrials.gov Identifier:
NCT01092988
First received: March 24, 2010
Last updated: February 19, 2012
Last verified: February 2012
History of Changes
  Purpose

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 Intervention
Uterine Fibroids
Bleeding
Pain
 Device: Exablate 2100

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by InSightec:

Primary Outcome Measures:
  • Safety [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 40
Study Start Date: March 2010
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exablate 2100
MR Guided Focused Ultrasound treatment
 Device: Exablate 2100
MR guided focused ultrasound

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01092988

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

Additional Information:
Sponsor's website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Clinical Project Manager, Insightec
ClinicalTrials.gov Identifier: NCT01092988     History of Changes
Other Study ID Numbers: UF032
Study First Received: March 24, 2010
Last Updated: February 19, 2012
Health Authority: Israel: Ethics Commission

Keywords provided by InSightec:
Uterine Fibroids
Bleeding
Pain
Quality of life
MR guided focused ultrasound

Additional relevant MeSH terms:
Hemorrhage
Leiomyoma
Myofibroma
Pathologic Processes
Neoplasms, Muscle Tissue
 Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases

ClinicalTrials.gov processed this record on May 19, 2013