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Uterine FibroidsPhase 3NCT00295217

MR Guided Focused Ultrasound Surgery in the Treatment of Uterine Fibroids: Software V4.2 Validation

A Phase 3 study testing ExAblate 2000 in people with Uterine Fibroids and Uterine Leiomyomas, run by InSightec at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this study is to validate the new ExAblate Application software V4.2 by developing additional data that shows the safety of this treatment. 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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Uterine Fibroids, Uterine Leiomyomas
What is being tested?
ExAblate 2000
Type of treatment
Medical device
How many people
15 participants
Where
4 sitesUnited States
Study dates
Feb 2006to Oct 2006
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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)
Show all 12Show fewer
  • 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

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Lahey Clinic

    Burlington, Massachusetts, 01805

  • KNI

    Kalamazoo, Michigan, 49048

  • University of California at San Diego

    La Jolla, California, 92037

  • Cornell Vascular

    New York, New York, 10022

Other trials in United States

About this study

Official title: MR Guided Focused Ultrasound Surgery in the Treatment of Uterine Fibroids: Clinical Study to Validate the Changes to ExAblate 2000 Device

The goal of this study is to validate the new ExAblate Application software V4.2 by developing additional data that shows the safety of this treatment. 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.

Being tested
ExAblate 2000
Keywords
Fibroids, Uterine Leiomyomas, ExAblate, MrgFUS
Medical subject headings
Leiomyoma, Myofibroma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExAblate 2000Device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. In this IDE for the 4.2 ExAblate system, the goal is evaluation of the new features to confirm that they do not introduce any new safety issues.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2006 (estimated)
  2. Study startFeb 2006
  3. Study completionOct 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00295217
Sponsor's protocol ID
UF017
Other IDs
Continued Access
Status last verified
Dec 2018
First submitted
21 Feb 2006
Last updated
20 Dec 2018
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ExAblate 2000 in people with Uterine Fibroids and Uterine Leiomyomas, run by InSightec at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

In this IDE for the 4.2 ExAblate system, the goal is evaluation of the new features to confirm that they do not introduce any new safety issues.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00295217.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2018.

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