NCT00365989

Brief Summary

This is a phase 3 study to determine the safety of the new features to the FDA approved ExAblate device using a new method to ablate fibroids deemed Enhanced Sonication.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2006

Geographic Reach
2 countries

5 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

August 17, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 18, 2006

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
10.5 years until next milestone

Results Posted

Study results publicly available

February 5, 2019

Completed
Last Updated

February 5, 2019

Status Verified

December 1, 2018

Enrollment Period

1.8 years

First QC Date

August 17, 2006

Results QC Date

December 20, 2018

Last Update Submit

February 4, 2019

Conditions

Uterine LeiomyomaUterine Fibroids

Keywords

Fibroidsleiomyomaneoplasmbenign tumors

Outcome Measures

Primary Outcomes (1)

  • Number of Adverse Events

    The study objective is to determine the safety of the new Enhanced Sonication technique and assure no new safety issues are introduced.

    Within 1 month of treatment

Other Outcomes (2)

  • Mean Enhanced Sonication Normalized Thermal Dose Volume

    During treatment

  • Number of Participants With Adverse Events

    Within 1 month of treatment

Study Arms (1)

ExAblate Enhanced Sonication Test Arm

EXPERIMENTAL

The intervention to be administered is ExAblate Enhanced Sonication. The purpose of this study is to examine the safety profile of the ExAblate Enhanced Sonication mode to insure that no new safety issues are introduced compared to the normal focused ultrasound mode.

Device: ExAblate Enhanced Sonication

Interventions

ExAblate Enhanced SonicationDEVICE
Also known as: Magnetic Resonance guided Focused Ultrasound
ExAblate Enhanced Sonication Test Arm

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women age 18 or older, who present with symptomatic fibroids
  • 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 (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.

You may not qualify if:

  • Women who are pregnant, as confirmed by serum test at time of screening, or urine pregnancy test on the day of treatment
  • Patient who desire to become pregnant in the future.
  • Patients who are breast-feeding.
  • Patients with an active pelvic inflammatory disease (PID)
  • Active local or systemic infection
  • Metallic implants that are incompatible with MRI
  • Known intolerance to the MRI contrast agent (e.g. Gadolinium or Magnevist)
  • Severe claustrophobia that would prevent completion of procedure in the MR unit.
  • Extensive abdominal scarring in the beam pass or dermoid cyst of the ovary anywhere in the treatment path.
  • Known or suspected pelvic carcinoma or pre-malignant conditions, including sarcoma and adenomatous hyperplasia.
  • Pedunculated fibroids.
  • Intrauterine device (IUD) anywhere in the treatment path
  • Undiagnosed vaginal bleeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of California at San Diego

La Jolla, California, 92037, United States

Location

Lahey Clinic

Burlington, Massachusetts, 01805, United States

Location

KNI

Kalamazoo, Michigan, 49048, United States

Location

Cornell Vascular

New York, New York, 10022, United States

Location

Toronto General Hospital

Toronto, Ontario, MG5 2C4, Canada

Location

Related Links

MeSH Terms

Conditions

MyofibromaLeiomyomaNeoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeConnective Tissue DiseasesSkin and Connective Tissue DiseasesNeoplasms, Muscle Tissue

Results Point of Contact

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

Study Officials

  • Anne Roberts, M.D.

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

  • Mark Shaman, M.D.

    KNI

    PRINCIPAL INVESTIGATOR

  • Robert Min, M.D.

    Cornell

    PRINCIPAL INVESTIGATOR

  • David Gianfelice, M.D.

    Toronto General Hospital

    PRINCIPAL INVESTIGATOR

  • George Holland, M.D.

    Lahey Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2006

First Posted

August 18, 2006

Study Start

October 1, 2006

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

February 5, 2019

Results First Posted

February 5, 2019

Record last verified: 2018-12

Locations

US(4)CA(1)