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Safety Study of ExAblate for the Treatment of Uterine Fibroids

Primary Purpose

Uterine Fibroids

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ExAblate
Sponsored by
InSightec
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Fibroids focused on measuring Uterine fibroids, MRgFUS, ExAblate, Focused Ultrasound, Symptomatic uterine fibroids

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • UCLA
  • UCSD Department of Radiology
  • University of California San Francisco
  • University Image Guided Therapy
  • Borgess Research Institute
  • Duke University
  • The Methodist Hospital Research Institute
  • University of Virginia Health System

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

ExAblate treatment

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
June 10, 2010
Last Updated
March 5, 2019
Sponsor
InSightec
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1. Study Identification

Unique Protocol Identification Number
NCT01142791
Brief Title
Safety Study of ExAblate for the Treatment of Uterine Fibroids
Official Title
A Phase IV Clinical Study To Evaluate the Safety of MR-Guided Focused Ultrasound Treatment of Uterine Fibroids With Enhanced Sonication Techniques
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
InSightec

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Fibroids
Keywords
Uterine fibroids, MRgFUS, ExAblate, Focused Ultrasound, Symptomatic uterine fibroids

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
121 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ExAblate treatment
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
ExAblate
Intervention Description
Magnetic resonance image-guided focused ultrasound (MRgFUS) for fibroid ablation
Primary Outcome Measure Information:
Title
Percent Occurrence of Chronic Leg Pain
Description
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.
Time Frame
From treatment to 1-month post-treatment

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). 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.
Facility Information:
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
UCSD Department of Radiology
City
San Diego
State/Province
California
ZIP/Postal Code
92103-8749
Country
United States
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94107
Country
United States
Facility Name
University Image Guided Therapy
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33431
Country
United States
Facility Name
Borgess Research Institute
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49048
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
The Methodist Hospital Research Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.insightec.com
Description
Sponsor's Web Page

Learn more about this trial

Safety Study of ExAblate for the Treatment of Uterine Fibroids

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