LeiomyomaNCT00131365
Magnetic Resonance (MR) Guided Focused Ultrasound Surgery of Uterine Fibroids
A study testing ExAblate 2000 in people with Leiomyoma, run by InSightec at 1 site in United States.
Trial summary
The goal of this study is to develop additional long term data to evaluate the safety and effectiveness of this treatment. Indications for use for this system is: 'The ExAblate is intended to ablate uterine fibroid tissue in pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine sparing… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Leiomyoma
- What is being tested?
- ExAblate 2000
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Feb 2009
- 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 Any age
- Women only
- No healthy volunteers
- Child, 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 magnetic resonance imaging (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
- Women 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
1 site in 1 country.
About this study
Official title: Post Approval Study: MR Guided Focused Ultrasound Surgery in the Treatment of Uterine Fibroids
The goal of this study is to develop additional long term data to evaluate the safety and effectiveness of this treatment.
Indications for use for this system is: '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.'
Read the detailed description
Background
General:
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. In general, these symptoms can be classified into two categories:
- heavy menstrual bleeding, defined as bleeding on heavy days requiring a change of sanitary wear every 2 hours or less, significant clot passage, flooding, substantial prolongation of menstrual periods compared with the patient's prior experience, or anemia.
- pelvic pain or pressure, heaviness or discomfort, or similar symptoms in the back, flank or leg attributable to the bulk of the fibroid, urinary frequency, increase in nocturia, difficulty voiding or compression of the ureters with hydronephrosis.
Measures of the clinical success of patients who elect treatment of fibroids are generally subjective, and evaluated by the patient in terms of improvement in the initial symptoms that caused her to seek treatment (decrease in pain, bladder or bowel symptoms, or reduction in vaginal bleeding), while experiencing a minimum of co-morbidities from the treatment itself.
ExAblate Device:
The InSightec ExAblate MR guided Focused Ultrasound Surgery (MRgFUS) system is a non-invasive thermal ablation device fully integrated with an MR imaging system and used for the ablation of soft tissue. It has been evaluated in an earlier FDA international, multi-center study and found to be safe and effective for the treatment of uterine fibroids. ExAblate device received FDA approval in October 2004.
Prior Studies:
The ExAblate has been used for the treatment of uterine fibroids in 2 previous IDE protocols.
- Group A: This was the original Pivotal Study Group (IDE G020001 - Protocol UF002). These 109 patients were treated at 3 sites in the US and at 4 sites outside the US. There was a limitation on the allowable treatment volume and only a single treatment was permitted. Original follow-up was planned for 6 months. The study was later extended to include follow-up visits at 12, 24, and 36 months (UF009). Because of the gap between the initial study consent, and the re-consent for the long term follow-up there was a high dropout rate at the 12 month visit. Thirty-three US patients returned for the 12 months visit, and will continue to be followed for the 24 and 36 M visits.
- Group B: This was the Continued Access Study (IDE G020001 - Protocol UF005) where approximately 160 patients were treated at 3 sites in the US during the PMA review period. Treatment conditions were modified somewhat from the pivotal, including the addition of a second treatment session where necessary. The initial study was planned to include a long term follow-up of 12, 24 and 36 months (UF009).
- Group C: This group of 70 patients (UF14) will be treated post-PMA approval following the commercial treatment guidelines. The follow-up will include for visits at 12, 24 and 36 months. This group includes also another 20 patients who will be treated under this original IDE to validate the ExAblate system for use in a 3T MR scanner, as well as validating a new application SW (V4.1).
- Conditions
- Leiomyoma
- Being tested
- ExAblate 2000
- Keywords
- fibroids, Uterine Fibroids, ExAblate, MrgFUS
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExAblate 2000Device
| Study group | Role | What they receive |
|---|---|---|
| ExAblate MRgFUS | Experimental | Treatment with the ExAblate 2000 system Version 4.1 Receives: Device: ExAblate 2000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and Type of Adverse Events
Adverse events outcomes are reported in the adverse events module.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2005 (estimated)
- Study startJan 2006
- Primary completionJan 2009
- Study completionFeb 2009
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 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- InSightec
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Min, M.D., Principal investigator, Cornell Vascular
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00131365
- Sponsor's protocol ID
- UF014 - 4.1/3T
- Status last verified
- May 2019
- First submitted
- 17 Aug 2005
- Last updated
- 12 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Approval Study: MR Guided Focused Ultrasound Surgery in the Treatment of Uterine Fibroids
- ClinicalTrials.gov ID
- NCT00131365
- Acronym / sponsor ID
- UF014 - 4.1/3T
- Conditions
- Leiomyoma
- Keywords
- fibroids, Uterine Fibroids, ExAblate, MrgFUS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- InSightecIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Primary completion
- Jan 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 18 Aug 2005 (estimated)
- Results
- Posted 12 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to develop additional long term data to evaluate the safety and effectiveness of this treatment.
Indications for use for this system is: '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.'
Detailed description
Background
General:
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. In general, these symptoms can be classified into two categories:
- heavy menstrual bleeding, defined as bleeding on heavy days requiring a change of sanitary wear every 2 hours or less, significant clot passage, flooding, substantial prolongation of menstrual periods compared with the patient's prior experience, or anemia.
- pelvic pain or pressure, heaviness or discomfort, or similar symptoms in the back, flank or leg attributable to the bulk of the fibroid, urinary frequency, increase in nocturia, difficulty voiding or compression of the ureters with hydronephrosis.
Measures of the clinical success of patients who elect treatment of fibroids are generally subjective, and evaluated by the patient in terms of improvement in the initial symptoms that caused her to seek treatment (decrease in pain, bladder or bowel symptoms, or reduction in vaginal bleeding), while experiencing a minimum of co-morbidities from the treatment itself.
ExAblate Device:
The InSightec ExAblate MR guided Focused Ultrasound Surgery (MRgFUS) system is a non-invasive thermal ablation device fully integrated with an MR imaging system and used for the ablation of soft tissue. It has been evaluated in an earlier FDA international, multi-center study and found to be safe and effective for the treatment of uterine fibroids. ExAblate device received FDA approval in October 2004.
Prior Studies:
The ExAblate has been used for the treatment of uterine fibroids in 2 previous IDE protocols.
- Group A: This was the original Pivotal Study Group (IDE G020001 - Protocol UF002). These 109 patients were treated at 3 sites in the US and at 4 sites outside the US. There was a limitation on the allowable treatment volume and only a single treatment was permitted. Original follow-up was planned for 6 months. The study was later extended to include follow-up visits at 12, 24, and 36 months (UF009). Because of the gap between the initial study consent, and the re-consent for the long term follow-up there was a high dropout rate at the 12 month visit. Thirty-three US patients returned for the 12 months visit, and will continue to be followed for the 24 and 36 M visits.
- Group B: This was the Continued Access Study (IDE G020001 - Protocol UF005) where approximately 160 patients were treated at 3 sites in the US during the PMA review period. Treatment conditions were modified somewhat from the pivotal, including the addition of a second treatment session where necessary. The initial study was planned to include a long term follow-up of 12, 24 and 36 months (UF009).
- Group C: This group of 70 patients (UF14) will be treated post-PMA approval following the commercial treatment guidelines. The follow-up will include for visits at 12, 24 and 36 months. This group includes also another 20 patients who will be treated under this original IDE to validate the ExAblate system for use in a 3T MR scanner, as well as validating a new application SW (V4.1).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ExAblate MRgFUS | Experimental | Device: ExAblate 2000Treatment with the ExAblate 2000 system Version 4.1 |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (12 listed)
- Metallic implants that are incompatible with MRI
- Sensitive to MRI contrast agents
- Severe claustrophobia that would prevent completion of procedure in MR unit
- Women 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
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 2000 | Device | ExAblate MRgFUS |
Primary outcome
Number and Type of Adverse Events
Time frame: 36 months
Adverse events outcomes are reported in the adverse events module.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Sponsor home 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.
Robert Min, M.D. principal investigator
Cornell Vascular
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ExAblate 2000 in people with Leiomyoma, run by InSightec at 1 site 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 12 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 12 Jun 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 and Type of Adverse Events (time frame: 36 months). 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 12 Jun 2019.