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ExAblate UF V2 System for the Treatment of Symptomatic Uterine Fibroids

Primary Purpose

Uterine Fibroids

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ExAblate Treatment UF V2
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 - 64 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patient age 18 or older
  2. Patients who present with symptomatic uterine fibroids and are not seeking treatment for the reason of improving fertility.
  3. Patients who have given written informed consent
  4. Patients who are able and willing to attend all study visits
  5. Patients who are pre or peri-menopausal (within 12 months of last menstrual period)
  6. Patients should have completed child bearing
  7. Able to communicate sensations during the ExAblate procedure.
  8. 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).
  9. Fibroid(s) clearly visible on non-contrast MRI.

Exclusion Criteria:

  1. Pregnant patients, as confirmed by serum/urine test at time of screening, or urine pregnancy test on the day of treatment. Pregnancies following ExAblate treatment could be dangerous for both mother and fetus.
  2. Uterine size >24 weeks.
  3. Patients with pedunculated fibroids
  4. Patients with active pelvic inflammatory disease (PID).
  5. Patients with active local or systemic infection
  6. Patients experiencing any symptoms of lower extremity neuropathy, including chronic leg or lower back pain, within the last 6 months

  7. Contraindication for MRI Scan:

    • Severe claustrophobia that would prevent completion of procedure in the MR unit
    • Metallic implants that are incompatible with MRI
    • Sensitivity to MRI contrast agents
    • Any other contraindication for MRI Scan
  8. Extensive abdominal scarring in the beam path (that cannot be avoided by redirection of the beam)
  9. Dermoid cyst of the ovary anywhere in the treatment path.
  10. Known or suspected pelvic carcinoma or pre-malignant conditions, including sarcoma and adenomatous hyperplasia.
  11. Intrauterine device (IUD) anywhere in the treatment path
  12. Undiagnosed vaginal bleeding

Sites / Locations

  • University of California, Los Angeles
  • University of California, San Francisco
  • Stanford University Medical Center
  • Brigham and Women's Hospital
  • Mayo Clinic
  • Duke University
  • Ohio Health Research Institute
  • University of Virginia Health System

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ExAblate treatment UF V2

Arm Description

ExAblate MRgFUS Treatment

Outcomes

Primary Outcome Measures

Percentage of Participants With Leg Pain or Lower Extremity Neuropathy Persisting or Occuring Greater Than 10 Days Following Treatment
The hypothesis for this study was that the percentage of subjects experiencing persistent leg pain would be less than 10%

Secondary Outcome Measures

Full Information

First Posted
January 27, 2011
Last Updated
February 19, 2019
Sponsor
InSightec
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1. Study Identification

Unique Protocol Identification Number
NCT01285960
Brief Title
ExAblate UF V2 System for the Treatment of Symptomatic Uterine Fibroids
Official Title
A Clinical Study to Evaluate Safety of the ExAblate Model 2100 Type 1.1 System (ExAblate 2100/2000 UF V2 System) in the Treatment of Symptomatic Uterine Fibroids
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (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 purpose of this study is to evaluate the safety and ablation efficacy of the ExAblate UF V2 System when treating symptomatic uterine fibroids. The ExAblate System is a medical device that involves a focused ultrasound system and an MRI scanner. ExAblate delivers a pulse of focused ultrasound energy, or sonication, to the targeted tissue. In this particular study, the targeted tissue is uterine fibroids. Each sonication is used to heat small spots in the fibroid much like a magnifying glass can be used to focus light to heat a spot. The heat created kills a portion of the fibroid with the goal of decreasing or eliminating uterine fibroid-related symptoms. Repeated sonications are performed until the entire fibroid is treated or the treated volume is determined to be appropriate. The ExAblate system is commercially approved in the United States to treat symptomatic uterine fibroids. The ExAblate UF V2 System is an experimental device and is being investigated in this study. While similar to the commercial system, the ExAblate UF V2 device includes the following major changes, among others, which are intended to improve device performance and safety: Up and down movement of the ultrasound transducer, in an attempt to improve fibroid treatment by moving the ultrasound focal point within the targeted fibroid. Ultrasound energy can be turned off for a specific area in an attempt to minimize amount of energy passing through sensitive areas of the body.

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
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ExAblate treatment UF V2
Arm Type
Experimental
Arm Description
ExAblate MRgFUS Treatment
Intervention Type
Device
Intervention Name(s)
ExAblate Treatment UF V2
Intervention Description
Treatment with the ExAblate UF V2 system. Patients may have up to two ExAblate treatments within a two-week period.
Primary Outcome Measure Information:
Title
Percentage of Participants With Leg Pain or Lower Extremity Neuropathy Persisting or Occuring Greater Than 10 Days Following Treatment
Description
The hypothesis for this study was that the percentage of subjects experiencing persistent leg pain would be less than 10%
Time Frame
From treatment to 1-month post-treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient age 18 or older Patients who present with symptomatic uterine fibroids and are not seeking treatment for the reason of improving fertility. Patients who have given written informed consent Patients who are able and willing to attend all study visits Patients who are pre or peri-menopausal (within 12 months of last menstrual period) Patients should have completed child bearing 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). Fibroid(s) clearly visible on non-contrast MRI. Exclusion Criteria: Pregnant patients, as confirmed by serum/urine test at time of screening, or urine pregnancy test on the day of treatment. Pregnancies following ExAblate treatment could be dangerous for both mother and fetus. Uterine size >24 weeks. Patients with pedunculated fibroids Patients with active pelvic inflammatory disease (PID). Patients with active local or systemic infection Patients experiencing any symptoms of lower extremity neuropathy, including 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 Metallic implants that are incompatible with MRI Sensitivity to MRI contrast agents 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
Facility Information:
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
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
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Ohio Health Research Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
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
https://www.insightec.com
Description
Sponsor's Web Page

Learn more about this trial

ExAblate UF V2 System for the Treatment of Symptomatic Uterine Fibroids

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