Uterine LeiomyomaPhase 3NCT00365989
MR Guided Focused Ultrasound Treatment of Uterine Fibroids With Enhanced Sonication
A Phase 3 study testing ExAblate Enhanced Sonication in people with Uterine Leiomyoma and Uterine Fibroids, run by InSightec at 5 sites in 2 countries.
Trial 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. 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 Leiomyoma, Uterine Fibroids
- What is being tested?
- ExAblate Enhanced Sonication
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Oct 2006to Aug 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 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.
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
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
About this study
Official title: A Clinical Study To Evaluate the Safety and Efficacy of MR Guided Focused Ultrasound Treatment of Uterine Fibroids With Enhanced Sonication Techniques
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.
Read the detailed description
Uterine leiomyoma (fibroids) are the most common neoplasms of the female pelvis. These benign tumors are generally oval in shape, and often highly vascular. On T2 weighted MR imaging exams, or T1 exams with contrast, uterine fibroids are easily identifiable. They occur in 20-25% of women of reproductive age and can cause a variety of problems generally described as either bleeding or mass effects from the fibroid. InSightec has developed an Enhanced Sonication (ES) technique for the ablation of these fibroids. This mode of tissue ablation has been added to the already FDA approved ExAblate system. The goal of this ES technique is to provide an additional treatment tool that will enhance the treatment effect without additional risks while preserving ALL clinical features of the current commercially approved version.
- Conditions
- Uterine Leiomyoma, Uterine Fibroids
- Being tested
- ExAblate Enhanced Sonication
- Keywords
- Fibroids, leiomyoma, neoplasm, benign tumors
- Medical subject headings
- Myofibroma, Leiomyoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExAblate Enhanced SonicationDevice
Also called Magnetic Resonance guided Focused Ultrasound
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: ExAblate Enhanced Sonication |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 1 month of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2006 (estimated)
- Study startOct 2006
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Uterine LeiomyomaStudies of the same condition, open and under way.
- More trials run by InSightecThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- InSightec
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anne Roberts, M.D., Principal investigator, University of California, San DiegoMark Shaman, M.D., Principal investigator, KNIRobert Min, M.D., Principal investigator, CornellDavid Gianfelice, M.D., Principal investigator, Toronto General HospitalGeorge Holland, M.D., Principal investigator, Lahey Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00365989
- Sponsor's protocol ID
- UF018
- Status last verified
- Dec 2018
- First submitted
- 17 Aug 2006
- Last updated
- 5 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study To Evaluate the Safety and Efficacy of MR Guided Focused Ultrasound Treatment of Uterine Fibroids With Enhanced Sonication Techniques
- ClinicalTrials.gov ID
- NCT00365989
- Acronym / sponsor ID
- UF018
- Conditions
- Uterine Leiomyoma, Uterine Fibroids
- Keywords
- Fibroids, leiomyoma, neoplasm, benign tumors
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- InSightecIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 18 Aug 2006 (estimated)
- Results
- Posted 5 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Uterine leiomyoma (fibroids) are the most common neoplasms of the female pelvis. These benign tumors are generally oval in shape, and often highly vascular. On T2 weighted MR imaging exams, or T1 exams with contrast, uterine fibroids are easily identifiable. They occur in 20-25% of women of reproductive age and can cause a variety of problems generally described as either bleeding or mass effects from the fibroid. InSightec has developed an Enhanced Sonication (ES) technique for the ablation of these fibroids. This mode of tissue ablation has been added to the already FDA approved ExAblate system. The goal of this ES technique is to provide an additional treatment tool that will enhance the treatment effect without additional risks while preserving ALL clinical features of the current commercially approved version.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ExAblate Enhanced Sonication Test Arm | Experimental | Device: ExAblate Enhanced SonicationThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExAblate Enhanced SonicationAlso: Magnetic Resonance guided Focused Ultrasound | Device | ExAblate Enhanced Sonication Test Arm |
Primary outcome
Number of Adverse Events
Time frame: Within 1 month of treatment
The study objective is to determine the safety of the new Enhanced Sonication technique and assure no new safety issues are introduced.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Sponsor web pageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Roberts, M.D. principal investigator
University of California, San Diego
Mark Shaman, M.D. principal investigator
KNI
Robert Min, M.D. principal investigator
Cornell
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ExAblate Enhanced Sonication in people with Uterine Leiomyoma and Uterine Fibroids, run by InSightec at 5 sites in 2 countries.
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 7 inclusion and 13 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 5 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Canada. 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?
Yes. Results are posted in the registry (first posted 5 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Adverse Events (time frame: Within 1 month of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Feb 2019.