Uterine FibroidsNCT01142791
Safety Study of ExAblate for the Treatment of Uterine Fibroids
A study testing ExAblate in people with Uterine Fibroids, run by InSightec at 8 sites in United States.
Trial summary
The objective of this Phase IV study is to evaluate the safety of the ExAblate treatment of uterine fibroids using the enhanced sonication techniques, based on the current commercially-approved treatment guidelines. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Fibroids
- What is being tested?
- ExAblate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 8 sitesUnited States
- Study dates
- May 2010to Apr 2012
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
- Patient should be family complete.
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- 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.
- Fibroid enhances on MR contrast imaging.
Who cannot join
- Women who are pregnant, as confirmed by serum/urine test at time of screening, or urine pregnancy test on the day of treatment.
- Patients who are breast-feeding.
- Patients with active pelvic inflammatory disease (PID).
- Patients with active local or systemic infection.
- Patients experiencing chronic leg or lower back pain within the last 6 months.
- Contraindication for MRI Scan:
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- Severe claustrophobia that would prevent completion of procedure in the MR unit
- Weight greater than 250 lbs (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 (that cannot be avoided by redirection of the beam).
- Dermoid cyst of the ovary anywhere in the treatment path.
- Known or suspected pelvic carcinoma or pre-malignant conditions, including sarcoma and adenomatous hyperplasia.
- Intrauterine device (IUD) anywhere in the treatment path.
- Undiagnosed vaginal bleeding.
- Pedunculated fibroids.
- Uterine size >24 weeks.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University Image Guided Therapy
Boca Raton, Florida, 33431
University of Virginia Health System
Charlottesville, Virginia, 22908
Duke University
Durham, North Carolina, 27705
The Methodist Hospital Research Institute
Houston, Texas, 77030
Borgess Research Institute
Kalamazoo, Michigan, 49048
UCLA
Los Angeles, California, 90095
UCSD Department of Radiology
San Diego, California, 92103-8749
University of California San Francisco
San Francisco, California, 94107
About this study
Official title: A Phase IV Clinical Study To Evaluate the Safety of MR-Guided Focused Ultrasound Treatment of Uterine Fibroids With Enhanced Sonication Techniques
The objective of this Phase IV study is to evaluate the safety of the ExAblate treatment of uterine fibroids using the enhanced sonication techniques, based on the current commercially-approved treatment guidelines. Treatment may include up to 100% of individual fibroid volume, within established serosal and sacral treatment margins.
The Enhanced sonication is one of the various sonication modes that may lead to increased thermal dose volume of each sonication without additional safety risks. This is an additional treatment tool available in the ExAblate system for the treatment of uterine fibroids.
The safety profile of the Enhanced Sonication was investigated under an FDA-regulated IDE study. FDA granted approval of Enhanced Sonication with the requirement to perform a post-approval study to collect additional safety data when treating up to 100% of individual fibroid volume.
- Conditions
- Uterine Fibroids
- Being tested
- ExAblate
- Keywords
- Uterine fibroids, MRgFUS, ExAblate, Focused Ultrasound, Symptomatic uterine fibroids
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExAblateDevice
Magnetic resonance image-guided focused ultrasound (MRgFUS) for fibroid ablation
| Study group | Role | What they receive |
|---|---|---|
| ExAblate treatment | Other | Not described Receives: Device: ExAblate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Occurrence of Chronic Leg Pain
The hypothesis was that over 90% of subjects would not experience chronic leg pain. A lower 95% Confidence Limit > 0.90 was considered statistically successful.
Measured: From treatment to 1-month post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2010 (estimated)
- Study startMay 2010
- Primary completionApr 2012
- Study completionApr 2012
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 FibroidsStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- InSightec
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01142791
- Sponsor's protocol ID
- UF033
- Status last verified
- Jan 2019
- First submitted
- 10 Jun 2010
- Last updated
- 19 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV Clinical Study To Evaluate the Safety of MR-Guided Focused Ultrasound Treatment of Uterine Fibroids With Enhanced Sonication Techniques
- ClinicalTrials.gov ID
- NCT01142791
- Acronym / sponsor ID
- UF033
- Conditions
- Uterine Fibroids
- Keywords
- Uterine fibroids, MRgFUS, ExAblate, Focused Ultrasound, Symptomatic uterine fibroids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- InSightecIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 11 Jun 2010 (estimated)
- Results
- Posted 6 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this Phase IV study is to evaluate the safety of the ExAblate treatment of uterine fibroids using the enhanced sonication techniques, based on the current commercially-approved treatment guidelines. Treatment may include up to 100% of individual fibroid volume, within established serosal and sacral treatment margins.
The Enhanced sonication is one of the various sonication modes that may lead to increased thermal dose volume of each sonication without additional safety risks. This is an additional treatment tool available in the ExAblate system for the treatment of uterine fibroids.
The safety profile of the Enhanced Sonication was investigated under an FDA-regulated IDE study. FDA granted approval of Enhanced Sonication with the requirement to perform a post-approval study to collect additional safety data when treating up to 100% of individual fibroid volume.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ExAblate treatment | Other | Device: ExAblate |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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).
Key exclusion criteria (18 listed)
- Women who are pregnant, as confirmed by serum/urine test at time of screening, or urine pregnancy test on the day of treatment.
- Patients who are breast-feeding.
- Patients with active pelvic inflammatory disease (PID).
- Patients with active local or systemic infection.
- Patients experiencing chronic leg or lower back pain within the last 6 months.
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 |
|---|---|---|
| ExAblateMagnetic resonance image-guided focused ultrasound (MRgFUS) for fibroid ablation | Device | ExAblate treatment |
Primary outcome
Percent Occurrence of Chronic Leg Pain
Time frame: From treatment to 1-month post-treatment
The hypothesis was that over 90% of subjects would not experience chronic leg pain. A lower 95% Confidence Limit > 0.90 was considered statistically successful.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Sponsor's 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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ExAblate in people with Uterine Fibroids, run by InSightec at 8 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 10 inclusion and 18 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 19 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Mar 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?
Percent Occurrence of Chronic Leg Pain (time frame: From treatment to 1-month post-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 19 Mar 2019; AzTrials last refreshed its copy on 8 Nov 2026.