Uterine FibroidsNCT01285960
ExAblate UF V2 System for the Treatment of Symptomatic Uterine Fibroids
A study testing ExAblate Treatment UF V2 in people with Uterine Fibroids, run by InSightec at 8 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and ablation efficacy of the ExAblate UF V2 System when treating symptomatic uterine fibroids. The ExAblate System is a medical device that involves a focused ultrasound system and an MRI scanner. Read more about this study
- Who is it for?
- Ages 18 to 64 years, women only
- Conditions the study is for
- Uterine Fibroids
- What is being tested?
- ExAblate Treatment UF V2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 8 sitesUnited States
- Study dates
- May 2012to Apr 2016
- 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 to 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patient age 18 or older
- Patients who present with symptomatic uterine fibroids and are not seeking treatment for the reason of improving fertility.
- Patients who have given written informed consent
- Patients who are able and willing to attend all study visits
- Patients who are pre or peri-menopausal (within 12 months of last menstrual period)
- Patients should have completed child bearing
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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).
- Fibroid(s) clearly visible on non-contrast MRI.
Who cannot join
- Pregnant patients, as confirmed by serum/urine test at time of screening, or urine pregnancy test on the day of treatment. Pregnancies following ExAblate treatment could be dangerous for both mother and fetus.
- Uterine size >24 weeks.
- Patients with pedunculated fibroids
- Patients with active pelvic inflammatory disease (PID).
- Patients with active local or systemic infection
- Patients experiencing any symptoms of lower extremity neuropathy, including chronic leg or lower back pain, within the last 6 months
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- Contraindication for MRI Scan:
- Severe claustrophobia that would prevent completion of procedure in the MR unit
- Metallic implants that are incompatible with MRI
- Sensitivity to MRI contrast agents
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
University of Virginia Health System
Charlottesville, Virginia, 22908
Ohio Health Research Institute
Columbus, Ohio, 43214
Duke University
Durham, North Carolina, 27705
University of California, Los Angeles
Los Angeles, California, 90095
Mayo Clinic
Rochester, Minnesota, 55905
University of California, San Francisco
San Francisco, California, 94107
Stanford University Medical Center
Stanford, California, 94305
About this study
Official title: A Clinical Study to Evaluate Safety of the ExAblate Model 2100 Type 1.1 System (ExAblate 2100/2000 UF V2 System) in the Treatment of Symptomatic Uterine Fibroids
The purpose of this study is to evaluate the safety and ablation efficacy of the ExAblate UF V2 System when treating symptomatic uterine fibroids.
The ExAblate System is a medical device that involves a focused ultrasound system and an MRI scanner. ExAblate delivers a pulse of focused ultrasound energy, or sonication, to the targeted tissue. In this particular study, the targeted tissue is uterine fibroids. Each sonication is used to heat small spots in the fibroid much like a magnifying glass can be used to focus light to heat a spot. The heat created kills a portion of the fibroid with the goal of decreasing or eliminating uterine fibroid-related symptoms. Repeated sonications are performed until the entire fibroid is treated or the treated volume is determined to be appropriate.
Read more
The ExAblate system is commercially approved in the United States to treat symptomatic uterine fibroids.
The ExAblate UF V2 System is an experimental device and is being investigated in this study. While similar to the commercial system, the ExAblate UF V2 device includes the following major changes, among others, which are intended to improve device performance and safety:
- Up and down movement of the ultrasound transducer, in an attempt to improve fibroid treatment by moving the ultrasound focal point within the targeted fibroid.
- Ultrasound energy can be turned off for a specific area in an attempt to minimize amount of energy passing through sensitive areas of the body.
- Conditions
- Uterine Fibroids
- Being tested
- ExAblate Treatment UF V2
- 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.
ExAblate Treatment UF V2Device
Treatment with the ExAblate UF V2 system. Patients may have up to two ExAblate treatments within a two-week period.
| Study group | Role | What they receive |
|---|---|---|
| ExAblate treatment UF V2 | Experimental | ExAblate MRgFUS Treatment Receives: Device: ExAblate Treatment UF V2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Leg Pain or Lower Extremity Neuropathy Persisting or Occuring Greater Than 10 Days Following Treatment
The hypothesis for this study was that the percentage of subjects experiencing persistent leg pain would be less than 10%
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 posted28 Jan 2011 (estimated)
- Study startMay 2012
- Primary completionApr 2016
- Study completionApr 2016
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- InSightec
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01285960
- Sponsor's protocol ID
- UF031
- Status last verified
- Feb 2019
- First submitted
- 27 Jan 2011
- Last updated
- 6 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Bitton RR, Fast A, Vu KN, Lum DA, Chen B, Hesley GK, Raman SS, Matsumoto AH, Price TM, Tempany C, Dhawan N, Dolen E, Kohi M, Fennessey FM, Ghanouni P. What predicts durable symptom relief of uterine fibroids treated with MRI-guided focused ultrasound? A multicenter trial in 8 academic centers. Eur Radiol. 2023 Nov;33(11):7360-7370. doi: 10.1007/s00330-023-09984-4. Epub 2023 Aug 9.
PubMed 37553488
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate Safety of the ExAblate Model 2100 Type 1.1 System (ExAblate 2100/2000 UF V2 System) in the Treatment of Symptomatic Uterine Fibroids
- ClinicalTrials.gov ID
- NCT01285960
- Acronym / sponsor ID
- UF031
- Conditions
- Uterine Fibroids
- Keywords
- Uterine fibroids, MRgFUS, ExAblate, Focused Ultrasound, Symptomatic uterine fibroids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- InSightecIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 28 Jan 2011 (estimated)
- Results
- Posted 19 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and ablation efficacy of the ExAblate UF V2 System when treating symptomatic uterine fibroids.
The ExAblate System is a medical device that involves a focused ultrasound system and an MRI scanner. ExAblate delivers a pulse of focused ultrasound energy, or sonication, to the targeted tissue. In this particular study, the targeted tissue is uterine fibroids. Each sonication is used to heat small spots in the fibroid much like a magnifying glass can be used to focus light to heat a spot. The heat created kills a portion of the fibroid with the goal of decreasing or eliminating uterine fibroid-related symptoms. Repeated sonications are performed until the entire fibroid is treated or the treated volume is determined to be appropriate.
The ExAblate system is commercially approved in the United States to treat symptomatic uterine fibroids.
The ExAblate UF V2 System is an experimental device and is being investigated in this study. While similar to the commercial system, the ExAblate UF V2 device includes the following major changes, among others, which are intended to improve device performance and safety:
- Up and down movement of the ultrasound transducer, in an attempt to improve fibroid treatment by moving the ultrasound focal point within the targeted fibroid.
- Ultrasound energy can be turned off for a specific area in an attempt to minimize amount of energy passing through sensitive areas of the body.
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 UF V2 | Experimental | Device: ExAblate Treatment UF V2ExAblate MRgFUS Treatment |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Patient age 18 or older
- Patients who present with symptomatic uterine fibroids and are not seeking treatment for the reason of improving fertility.
- Patients who have given written informed consent
- Patients who are able and willing to attend all study visits
- Patients who are pre or peri-menopausal (within 12 months of last menstrual period)
Key exclusion criteria (16 listed)
- Pregnant patients, as confirmed by serum/urine test at time of screening, or urine pregnancy test on the day of treatment. Pregnancies following ExAblate treatment could be dangerous for both mother and fetus.
- Uterine size >24 weeks.
- Patients with pedunculated fibroids
- Patients with active pelvic inflammatory disease (PID).
- Patients with 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 Treatment UF V2Treatment with the ExAblate UF V2 system. Patients may have up to two ExAblate treatments within a two-week period. | Device | ExAblate treatment UF V2 |
Primary outcome
Percentage of Participants With Leg Pain or Lower Extremity Neuropathy Persisting or Occuring Greater Than 10 Days Following Treatment
Time frame: From treatment to 1-month post-treatment
The hypothesis for this study was that the percentage of subjects experiencing persistent leg pain would be less than 10%
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37553488Bitton RR, Fast A, Vu KN, Lum DA, Chen B, Hesley GK, Raman SS, Matsumoto AH, Price TM, Tempany C, Dhawan N, Dolen E, Kohi M, Fennessey FM, Ghanouni P. What predicts durable symptom relief of uterine fibroids treated with MRI-guided focused ultrasound? A multicenter trial in 8 academic centers. Eur Radiol. 2023 Nov;33(11):7360-7370. doi: 10.1007/s00330-023-09984-4. Epub 2023 Aug 9.
- 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 Treatment UF V2 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 9 inclusion and 16 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 6 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 19 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?
Percentage of Participants With Leg Pain or Lower Extremity Neuropathy Persisting or Occuring Greater Than 10 Days Following Treatment (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?
On the ClinicalTrials.gov record for NCT01285960, which also lists 1 linked publication.
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 6 Mar 2019.