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: April 12, 2012

Last verified: April 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	June 10, 2010
Last Updated Date	April 12, 2012
Start Date ^ICMJE	May 2010
Primary Completion Date	April 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 10, 2010)	Chronic leg pain [ Time Frame: From treatment to 1-month post-treatment ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01142791 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Safety Study of ExAblate for the Treatment of Uterine Fibroids
Official Title ^ICMJE	A Phase IV Clinical Study To Evaluate the Safety of MR-Guided Focused Ultrasound Treatment of Uterine Fibroids With Enhanced Sonication Techniques
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Uterine Fibroids
Intervention ^ICMJE	Device: ExAblate Magnetic resonance image-guided focused ultrasound (MRgFUS) for fibroid ablation
Study Arm (s)	ExAblate treatment Intervention: Device: ExAblate
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	115
Completion Date	April 2012
Primary Completion Date	April 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Female
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01142791
Other Study ID Numbers ^ICMJE	UF033
Has Data Monitoring Committee	No
Responsible Party	InSightec
Study Sponsor ^ICMJE	InSightec
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	InSightec
Verification Date	April 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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