MR Guided Focused Ultrasound Treatment of Uterine Fibroids With Enhanced Sonication

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
InSightec
ClinicalTrials.gov Identifier:
NCT00365989
First received: August 17, 2006
Last updated: September 13, 2012
Last verified: September 2012

August 17, 2006
September 13, 2012
October 2006
August 2008   (final data collection date for primary outcome measure)
The primary end point is to determine the safety of the new Enhanced Sonication technique and assure no new safety issues are introduced. [ Time Frame: Within 1 month of treatment ] [ Designated as safety issue: No ]
The primary end point is to determine the safety of the new Enhanced Sonication technique and assure no new safety issues are introduced.
Complete list of historical versions of study NCT00365989 on ClinicalTrials.gov Archive Site
The secondary end point of the study is to evaluate the ratio of normalized Enhanced Sonication thermal dose volume Vs. that of 'nominal' sonication. [ Time Frame: Within 1 month of treatment ] [ Designated as safety issue: No ]
The secondary end point of the study is to evaluate the ratio of normalized Enhanced Sonication thermal dose volume Vs. that of ‘nominal’ sonication.
Not Provided
Not Provided
 
MR Guided Focused Ultrasound Treatment of Uterine Fibroids With Enhanced Sonication
A Clinical Study To Evaluate the Safety and Efficacy of MR Guided Focused Ultrasound Treatment of Uterine Fibroids With Enhanced Sonication Techniques

This is a phase 3 study to determine the safety of the new features to the FDA approved ExAblate device using a new method to ablate fibroids deemed Enhanced Sonication.

Uterine leiomyoma (fibroids) are the most common neoplasms of the female pelvis. These benign tumors are generally oval in shape, and often highly vascular. On T2 weighted MR imaging exams, or T1 exams with contrast, uterine fibroids are easily identifiable. They occur in 20-25% of women of reproductive age and can cause a variety of problems generally described as either bleeding or mass effects from the fibroid. InSightec has developed an Enhanced Sonication (ES) technique for the ablation of these fibroids. This mode of tissue ablation has been added to the already FDA approved ExAblate system. The goal of this ES technique is to provide an additional treatment tool that will enhance the treatment effect without additional risks while preserving ALL clinical features of the current commercially approved version.

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Uterine Leiomyoma
  • Uterine Fibroids
Device: ExAblate 2000
Experimental: 1
Intervention: Device: ExAblate 2000
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
August 2008
August 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Women age 18 or older, who present with symptomatic fibroids
  2. Women who have given written informed consent
  3. Women who are able and willing to attend all study visits.
  4. Patient is pre or peri-menopausal (within 12 months of last menstrual period).
  5. Able to communicate sensations during the ExAblate procedure.
  6. Uterine fibroids, which are device accessible (i.e., positioned in the uterus such that they can be accessed without being shielded by bowel or bone).
  7. Fibroids(s) clearly visible on non-contrast MRI.

Exclusion Criteria:

  1. Women who are pregnant, as confirmed by serum test at time of screening, or urine pregnancy test on the day of treatment
  2. Patient who desire to become pregnant in the future.
  3. Patients who are breast-feeding.
  4. Patients with an active pelvic inflammatory disease (PID)
  5. Active local or systemic infection
  6. Metallic implants that are incompatible with MRI
  7. Known intolerance to the MRI contrast agent (e.g. Gadolinium or Magnevist)
  8. Severe claustrophobia that would prevent completion of procedure in the MR unit.
  9. Extensive abdominal scarring in the beam pass or dermoid cyst of the ovary anywhere in the treatment path.
  10. Known or suspected pelvic carcinoma or pre-malignant conditions, including sarcoma and adenomatous hyperplasia.
  11. Pedunculated fibroids.
  12. Intrauterine device (IUD) anywhere in the treatment path
  13. Undiagnosed vaginal bleeding.
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00365989
UF018
Not Provided
InSightec
InSightec
Not Provided
Principal Investigator: Anne Roberts, M.D. University of California, San Diego
Principal Investigator: Mark Shaman, M.D. KNI
Principal Investigator: Robert Min, M.D. Cornell
Principal Investigator: David Gianfelice, M.D. Toronto General Hospital
Principal Investigator: George Holland, M.D. Lahey Clinic
InSightec
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP