NCT01285960

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

8 active sites

Status
completed

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

First Submitted

Initial submission to the registry

January 27, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 28, 2011

Completed
1.3 years until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

February 19, 2019

Completed
Last Updated

March 6, 2019

Status Verified

February 1, 2019

Enrollment Period

3.9 years

First QC Date

January 27, 2011

Results QC Date

January 3, 2019

Last Update Submit

February 19, 2019

Conditions

Uterine Fibroids

Keywords

Uterine fibroidsMRgFUSExAblateFocused UltrasoundSymptomatic uterine fibroids

Outcome Measures

Primary Outcomes (1)

  • 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%

    From treatment to 1-month post-treatment

Study Arms (1)

ExAblate treatment UF V2

EXPERIMENTAL

ExAblate MRgFUS Treatment

Device: ExAblate Treatment UF V2

Interventions

ExAblate Treatment UF V2DEVICE

Treatment with the ExAblate UF V2 system. Patients may have up to two ExAblate treatments within a two-week period.

ExAblate treatment UF V2

Eligibility Criteria

Age18 Years - 64 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

University of California, San Francisco

San Francisco, California, 94107, United States

Location

Stanford University Medical Center

Stanford, California, 94305, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Duke University

Durham, North Carolina, 27705, United States

Location

Ohio Health Research Institute

Columbus, Ohio, 43214, United States

Location

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

Related Publications (1)

  • Bitton RR, Fast A, Vu KN, Lum DA, Chen B, Hesley GK, Raman SS, Matsumoto AH, Price TM, Tempany C, Dhawan N, Dolen E, Kohi M, Fennessey FM, Ghanouni P. What predicts durable symptom relief of uterine fibroids treated with MRI-guided focused ultrasound? A multicenter trial in 8 academic centers. Eur Radiol. 2023 Nov;33(11):7360-7370. doi: 10.1007/s00330-023-09984-4. Epub 2023 Aug 9.

    PMID: 37553488DERIVED

Related Links

MeSH Terms

Conditions

Leiomyoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Results Point of Contact

Title
Nadir Alikacem
Organization
InSightec
nadira@insightec.com
214-630-2000

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

January 27, 2011

First Posted

January 28, 2011

Study Start

May 1, 2012

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

March 6, 2019

Results First Posted

February 19, 2019

Record last verified: 2019-02

Locations

US(8)