Back to resultsA Clinical Study to Evaluate Safety of the ExAblate 2100 UF V2 System in the Treatment of Symptomatic Uterine Fibroids
Primary Purpose
Uterine Fibroids, Bleeding, Pain
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Exablate 2100
Sponsored by
About this trial
This is an interventional treatment trial for Uterine Fibroids focused on measuring Uterine Fibroids, Bleeding, Pain, Quality of life, MR guided focused ultrasound
Eligibility Criteria
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)
- Able to communicate sensations during the ExAblate procedure.
- Uterine fibroids, which are device accessible
- Fibroid(s) clearly visible on non-contrast MRI.
- Fibroid(s) 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
- Uterine size > 24 weeks
- Patients who are breast-feeding
- Patients with active pelvic inflammatory disease (PID).
- Patients with active local or systemic infection
Contraindication for MRI Scan:
- Severe claustrophobia that would prevent completion of procedure in the MR unit
- Weight greater than 250 IBS (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
- Dermoid cyst obstructing the treatment path.
- Known pelvic malignant or pre-malignant conditions
- Intrauterine device (IUD) anywhere in the treatment path
Sites / Locations
- Radiopharmaceutiques hopital Bretonneau
- Sheba MC
- Research Centre of Obstetric / Gynaecology & Perinatology
- St. Mary's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Exablate 2100
Arm Description
MR Guided Focused Ultrasound treatment
Outcomes
Primary Outcome Measures
Safety
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01092988
Brief Title
A Clinical Study to Evaluate Safety of the ExAblate 2100 UF V2 System in the Treatment of Symptomatic Uterine Fibroids
Official Title
A Clinical Study to Evaluate Safety of the ExAblate 2100 UF V2 System in the Treatment of Symptomatic Uterine Fibroids
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
InSightec
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Fibroids, Bleeding, Pain
Keywords
Uterine Fibroids, Bleeding, Pain, Quality of life, MR guided focused ultrasound
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exablate 2100
Arm Type
Experimental
Arm Description
MR Guided Focused Ultrasound treatment
Intervention Type
Device
Intervention Name(s)
Exablate 2100
Intervention Description
MR guided focused ultrasound
Primary Outcome Measure Information:
Title
Safety
Description
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.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Initial Efficacy
Description
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
Time Frame
1 month
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Able to communicate sensations during the ExAblate procedure.
Uterine fibroids, which are device accessible
Fibroid(s) clearly visible on non-contrast MRI.
Fibroid(s) 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
Uterine size > 24 weeks
Patients who are breast-feeding
Patients with active pelvic inflammatory disease (PID).
Patients with active local or systemic infection
Contraindication for MRI Scan:
Severe claustrophobia that would prevent completion of procedure in the MR unit
Weight greater than 250 IBS (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
Dermoid cyst obstructing the treatment path.
Known pelvic malignant or pre-malignant conditions
Intrauterine device (IUD) anywhere in the treatment path
Facility Information:
Facility Name
Radiopharmaceutiques hopital Bretonneau
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Sheba MC
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Research Centre of Obstetric / Gynaecology & Perinatology
City
Moscow
Country
Russian Federation
Facility Name
St. Mary's Hospital
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom
12. IPD Sharing Statement
Links:
URL
http://www.Insightec.com
Description
Sponsor's website
Learn more about this trial
A Clinical Study to Evaluate Safety of the ExAblate 2100 UF V2 System in the Treatment of Symptomatic Uterine Fibroids
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