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
1 other identifier
interventional
121
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2010
Typical duration for not_applicable
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 10, 2010
CompletedFirst Posted
Study publicly available on registry
June 11, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedResults Posted
Study results publicly available
March 6, 2019
CompletedMarch 19, 2019
January 1, 2019
1.9 years
June 10, 2010
January 4, 2019
March 5, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent Occurrence of Chronic Leg Pain
The hypothesis was that over 90% of subjects would not experience chronic leg pain. A lower 95% Confidence Limit \> 0.90 was considered statistically successful.
From treatment to 1-month post-treatment
Study Arms (1)
ExAblate treatment
OTHERInterventions
Magnetic resonance image-guided focused ultrasound (MRgFUS) for fibroid ablation
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- InSighteclead
Study Sites (8)
UCLA
Los Angeles, California, 90095, United States
UCSD Department of Radiology
San Diego, California, 92103-8749, United States
University of California San Francisco
San Francisco, California, 94107, United States
University Image Guided Therapy
Boca Raton, Florida, 33431, United States
Borgess Research Institute
Kalamazoo, Michigan, 49048, United States
Duke University
Durham, North Carolina, 27705, United States
The Methodist Hospital Research Institute
Houston, Texas, 77030, United States
University of Virginia Health System
Charlottesville, Virginia, 22908, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Nadir Alikacem
- Organization
- InSightec
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2010
First Posted
June 11, 2010
Study Start
May 1, 2010
Primary Completion
April 1, 2012
Study Completion
April 1, 2012
Last Updated
March 19, 2019
Results First Posted
March 6, 2019
Record last verified: 2019-01