NCT00131365

Brief Summary

The goal of this study is to develop additional long term data to evaluate the safety and effectiveness of this treatment. Indications for use for this system is: 'The ExAblate is intended to ablate uterine fibroid tissue in pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure. Patients must have a uterine size of less than 24 weeks and not seeking treatment for reasons of improving fertility.'

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 18, 2005

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2006

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
10.4 years until next milestone

Results Posted

Study results publicly available

June 12, 2019

Completed
Last Updated

June 12, 2019

Status Verified

May 1, 2019

Enrollment Period

3 years

First QC Date

August 17, 2005

Results QC Date

March 5, 2019

Last Update Submit

May 23, 2019

Conditions

Leiomyoma

Keywords

fibroidsUterine FibroidsExAblateMrgFUS

Outcome Measures

Primary Outcomes (1)

  • Number and Type of Adverse Events

    Adverse events outcomes are reported in the adverse events module.

    36 months

Study Arms (1)

ExAblate MRgFUS

EXPERIMENTAL

Treatment with the ExAblate 2000 system Version 4.1

Device: ExAblate 2000

Interventions

ExAblate 2000DEVICE
ExAblate MRgFUS

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (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 magnetic resonance imaging (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
  • Women 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 (1)

Cornell Vascular

New York, New York, 10022, United States

Location

Related Links

MeSH Terms

Conditions

Leiomyoma

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

This study was closed to enrollment in 2005 due to obsolescence of device features. Only safety data on the 9 enrolled participants was reported.

Results Point of Contact

Title
Nadir Alikacem
Organization
InSightec
nadira@insightec.com
214.630.2000

Study Officials

  • Robert Min, M.D.

    Cornell Vascular

    PRINCIPAL INVESTIGATOR

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

August 17, 2005

First Posted

August 18, 2005

Study Start

January 1, 2006

Primary Completion

January 1, 2009

Study Completion

February 1, 2009

Last Updated

June 12, 2019

Results First Posted

June 12, 2019

Record last verified: 2019-05

Locations

US(1)