NCT00166270

Brief Summary

This is a prospective, nonrandomized, multi-center study to evaluate the safety and effectiveness of ExAblate in the treatment of uterine fibroids. All patients will be treated and then followed for 36 months to evaluate the change in their fibroid symptoms.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

6 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

Study Start

First participant enrolled

January 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

July 9, 2018

Status Verified

July 1, 2018

Enrollment Period

1.2 years

First QC Date

September 9, 2005

Last Update Submit

July 6, 2018

Conditions

Uterine Fibroids

Keywords

FibroidsExAblateMrgFusUterine Fibroids

Outcome Measures

Primary Outcomes (1)

  • Measures of the clinical success of patients who elect treatment of fibroids are generally subjective, and evaluated by the patient in terms of improvement.

    Within 1 month of Treatment

Study Arms (1)

1

EXPERIMENTAL
Device: ExAblate 2000

Interventions

ExAblate 2000DEVICE
1

Eligibility Criteria

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

You may qualify if:

  • Women who present with symptomatic uterine fibroids and are not seeking treatment for the reason of improving fertility.
  • Able and willing to give consent and able 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:

  • Metallic implants that are incompatible with MRI
  • Sensitive to MRI contrast agents
  • Severe claustrophobia that would prevent completion of procedure in MR unit
  • Who are pregnant or desire to become pregnant in the future. Pregnancies following ExAblate treatment could be dangerous for both mother and fetus.
  • Pedunculated fibroids
  • Active pelvic inflammatory disease (PID)
  • Active local or systemic infection
  • Known or suspected pelvic carcinoma or pre-malignant conditions, including sarcoma and adenomatous hyperplasia
  • Intrauterine device (IUD) anywhere in the treatment path
  • Dermoid cyst of the ovary anywhere in the treatment path
  • Extensive abdominal scarring that cannot be avoided by redirection of the beam (e.g., due to Caesarean section or repeated abdominal surgeries)
  • Undiagnosed vaginal bleeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Radnet Management

Los Angeles, California, 90025, United States

Location

University MRI

Boca Raton, Florida, 33431, United States

Location

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Lahey Clinic

Burlington, Massachusetts, 01805, United States

Location

Virtua

Voorhees Township, New Jersey, 08043, United States

Location

North Texas Uterine Fibroid Institute

Plano, Texas, 75093, United States

Location

Related Links

MeSH Terms

Conditions

Leiomyoma

Condition Hierarchy (Ancestors)

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

Study Officials

  • Phyllis Gee, M.D.

    North Texas UFI

    PRINCIPAL INVESTIGATOR

  • Paul Curtis, M.D.

    Virtua

    PRINCIPAL INVESTIGATOR

  • George Holland, M.D.

    Lahey Clinic

    PRINCIPAL INVESTIGATOR

  • Dennis Sarti, M.D.

    Radnet Management

    PRINCIPAL INVESTIGATOR

  • Fred Steinberg, M.D.

    Univeristy MRI

    PRINCIPAL INVESTIGATOR

  • Elizabeth Stewart, M.D.

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

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

September 9, 2005

First Posted

September 14, 2005

Study Start

January 1, 2005

Primary Completion

April 1, 2006

Study Completion

January 1, 2009

Last Updated

July 9, 2018

Record last verified: 2018-07

Locations

US(6)