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Safety Study of ExAblate for the Treatment of Uterine Fibroids

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
InSightec
ClinicalTrials.gov Identifier:
NCT01142791
First received: June 10, 2010
Last updated: July 28, 2014
Last verified: July 2014

June 10, 2010
July 28, 2014
May 2010
April 2012   (final data collection date for primary outcome measure)
Chronic leg pain [ Time Frame: From treatment to 1-month post-treatment ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01142791 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Safety Study of ExAblate for the Treatment of Uterine Fibroids
A Phase IV Clinical Study To Evaluate the Safety of MR-Guided Focused Ultrasound Treatment of Uterine Fibroids With Enhanced Sonication Techniques

The objective of this Phase IV study is to evaluate the safety of the ExAblate treatment of uterine fibroids using the enhanced sonication techniques, based on the current commercially-approved treatment guidelines. Treatment may include up to 100% of individual fibroid volume, within established serosal and sacral treatment margins.

The Enhanced sonication is one of the various sonication modes that may lead to increased thermal dose volume of each sonication without additional safety risks. This is an additional treatment tool available in the ExAblate system for the treatment of uterine fibroids.

The safety profile of the Enhanced Sonication was investigated under an FDA-regulated IDE study. FDA granted approval of Enhanced Sonication with the requirement to perform a post-approval study to collect additional safety data when treating up to 100% of individual fibroid volume.

Not Provided
Interventional
Phase 4
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Uterine Fibroids
Device: ExAblate
Magnetic resonance image-guided focused ultrasound (MRgFUS) for fibroid ablation
ExAblate treatment
Intervention: Device: ExAblate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
115
April 2012
April 2012   (final data collection date for primary outcome measure)

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).
  • Patient should be family complete.
  • Able to communicate sensations during the ExAblate procedure.
  • 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).
  • Fibroids(s) clearly visible on non-contrast MRI.
  • Fibroid 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.
  • Patients who are breast-feeding.
  • Patients with active pelvic inflammatory disease (PID).
  • Patients with active local or systemic infection.
  • Patients experiencing chronic leg or lower back pain within the last 6 months.
  • Contraindication for MRI Scan:

    • Severe claustrophobia that would prevent completion of procedure in the MR unit
    • Weight greater than 250 lbs (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 (that cannot be avoided by redirection of the beam).
  • Dermoid cyst of the ovary anywhere in the treatment path.
  • Known or suspected pelvic carcinoma or pre-malignant conditions, including sarcoma and adenomatous hyperplasia.
  • Intrauterine device (IUD) anywhere in the treatment path.
  • Undiagnosed vaginal bleeding.
  • Pedunculated fibroids.
  • Uterine size >24 weeks.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01142791
UF033
No
InSightec
InSightec
Not Provided
Not Provided
InSightec
July 2014

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