NCT01092988

Brief Summary

The first magnetic resonance-guided focused ultrasound (MRgFUS) treatment of uterine fibroid using the ExAblate 2000 system was performed in 2001. Since then, more than 5000 treatments were done in more than 60 different hospitals around the world. The experience accumulated in this novel treatment was collected by InSightec and implemented into software and hardware updates, clinical tips and guidelines, all aimed to improve the clinical results and their durability, while maintaining a high level of safety. Based on extensive clinical experience and our internal research and development effort goals toward continuous improvement in ExAblate treatment safety and performance, limited changes have been made to the current ExAblate system. This modified ExAblate system version is designated as the ExAblate 2100 UF V2 system. The modifications are believed to improve system's friendliness to the user, without introducing new risks or other issues of safety of the device, and should not have any negative impact on the safety or technical efficacy of the treatments for patients.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2010

Typical duration for not_applicable

Geographic Reach
4 countries

4 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

March 1, 2010

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

March 24, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 25, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

February 22, 2012

Status Verified

February 1, 2012

Enrollment Period

1.9 years

First QC Date

March 24, 2010

Last Update Submit

February 19, 2012

Conditions

Uterine FibroidsBleedingPain

Keywords

Uterine FibroidsBleedingPainQuality of lifeMR guided focused ultrasound

Outcome Measures

Primary Outcomes (1)

  • Safety

    Safety of ExAblate 2100 UF V2 will be determined by an evaluation of the incidence and severity of device- and procedure-related adverse events from the first visit through 1-month post-treatment.

    1 month

Secondary Outcomes (1)

  • Initial Efficacy

    1 month

Study Arms (1)

Exablate 2100

EXPERIMENTAL

MR Guided Focused Ultrasound treatment

Device: Exablate 2100

Interventions

Exablate 2100DEVICE

MR guided focused ultrasound

Exablate 2100

Eligibility Criteria

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

You may qualify if:

  • Women age 18 or older
  • Symptomatic uterine fibroids, defined as those resulting in scores of 21 or higher, based on patient responses to questions 1-8 of the Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL).
  • 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
  • Fibroid(s) clearly visible on non-contrast MRI.
  • Fibroid(s) enhances on MR contrast imaging

You may not qualify if:

  • Women who are pregnant, as confirmed by serum/urine test at time of screening, or urine pregnancy test on the day of treatment
  • Uterine size \> 24 weeks
  • Patients who are breast-feeding
  • Patients with active pelvic inflammatory disease (PID).
  • Patients with active local or systemic infection
  • Contraindication for MRI Scan:
  • Severe claustrophobia that would prevent completion of procedure in the MR unit
  • Weight greater than 250 IBS (113Kg)
  • Implanted ferromagnetic materials and/or devices contraindicated for MR scan
  • Known intolerance to MRI contrast agent (e.g. Gadolinium or Magnevist)
  • Any other contraindication for MRI Scan
  • Extensive abdominal scarring in the beam path
  • Dermoid cyst obstructing the treatment path.
  • Known pelvic malignant or pre-malignant conditions
  • Intrauterine device (IUD) anywhere in the treatment path

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Radiopharmaceutiques hopital Bretonneau

Tours, 37044, France

Location

Sheba MC

Ramat Gan, 52621, Israel

Location

Research Centre of Obstetric / Gynaecology & Perinatology

Moscow, Russia

Location

St. Mary's Hospital

London, W2 1NY, United Kingdom

Location

Related Links

MeSH Terms

Conditions

LeiomyomaHemorrhagePain

Condition Hierarchy (Ancestors)

Neoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 24, 2010

First Posted

March 25, 2010

Study Start

March 1, 2010

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

February 22, 2012

Record last verified: 2012-02

Locations

IL(1)FR(1)GB(1)RU(1)