Uterine FibroidsNCT00166270
MR Guided Focused Ultrasound Surgery in the Treatment of Uterine Fibroids
A study testing ExAblate 2000 in people with Uterine Fibroids, run by InSightec at 6 sites in United States.
Trial summary
This is a prospective, nonrandomized, multi-center study to evaluate the safety and effectiveness of ExAblate in the treatment of uterine fibroids. All patients will be treated and then followed for 36 months to evaluate the change in their fibroid symptoms. 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 2000
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 6 sitesUnited States
- Study dates
- Jan 2005to Jan 2009
- Phase
- Interventional
- 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
- No healthy volunteers
- 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
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University MRI
Boca Raton, Florida, 33431
Brigham & Women's Hospital
Boston, Massachusetts, 02115
Lahey Clinic
Burlington, Massachusetts, 01805
Radnet Management
Los Angeles, California, 90025
North Texas Uterine Fibroid Institute
Plano, Texas, 75093
Virtua
Voorhees Township, New Jersey, 08043
About this study
Official title: Post Approval Study: MR Guided Focused Ultrasound Surgery in the Treatment of Uterine Fibroids
This is a prospective, nonrandomized, multi-center study to evaluate the safety and effectiveness of ExAblate in the treatment of uterine fibroids. All patients will be treated and then followed for 36 months to evaluate the change in their fibroid symptoms.
Read the detailed description
After the PMA Panel, the sponsor was requested to conduct a post-approval study. The objective of this study is to gather additional data to evaluate the safety and long term effectiveness of focused ultrasound treatment, and to include a larger cohort of African-American patients. Patients will be treated following the approved commercial treatment guidelines.
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.
- Conditions
- Uterine Fibroids
- Being tested
- ExAblate 2000
- Keywords
- Fibroids, ExAblate, MrgFus, 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 2000Device
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Device: ExAblate 2000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measures of the clinical success of patients who elect treatment of fibroids are generally subjective, and evaluated by the patient in terms of improvement.
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 posted14 Sep 2005 (estimated)
- Study startJan 2005
- Primary completionApr 2006
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- InSightec
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Phyllis Gee, M.D., Principal investigator, North Texas UFIPaul Curtis, M.D., Principal investigator, VirtuaGeorge Holland, M.D., Principal investigator, Lahey ClinicDennis Sarti, M.D., Principal investigator, Radnet ManagementFred Steinberg, M.D., Principal investigator, Univeristy MRIElizabeth Stewart, M.D., Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00166270
- Sponsor's protocol ID
- UF014
- Status last verified
- Jul 2018
- First submitted
- 9 Sep 2005
- Last updated
- 9 Jul 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2018. 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
- NCT00166270
- Acronym / sponsor ID
- UF014
- Conditions
- Uterine Fibroids
- Keywords
- Fibroids, ExAblate, MrgFus, Uterine Fibroids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- InSightecIndustry (pharma, biotech, devices)
- Study start
- Jan 2005
- Primary completion
- Apr 2006 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 14 Sep 2005 (estimated)
- Results
- Not posted in the source record
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 prospective, nonrandomized, multi-center study to evaluate the safety and effectiveness of ExAblate in the treatment of uterine fibroids. All patients will be treated and then followed for 36 months to evaluate the change in their fibroid symptoms.
Detailed description
After the PMA Panel, the sponsor was requested to conduct a post-approval study. The objective of this study is to gather additional data to evaluate the safety and long term effectiveness of focused ultrasound treatment, and to include a larger cohort of African-American patients. Patients will be treated following the approved commercial treatment guidelines.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: ExAblate 2000 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- 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
- 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 | 1 |
Primary outcome
Measures of the clinical success of patients who elect treatment of fibroids are generally subjective, and evaluated by the patient in terms of improvement.
Time frame: Within 1 month of Treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2018.
- Sponsor web pageLink provided by the sponsor.
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Life Study: Lifestyle Intervention in Fibroid Elimination
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Office Hysteroscopy Versus Operating-room Hysteroscopy for Uterine Lesions
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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.
Phyllis Gee, M.D. principal investigator
North Texas UFI
Paul Curtis, M.D. principal investigator
Virtua
George Holland, M.D. principal investigator
Lahey Clinic
6 sites 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 Uterine Fibroids, run by InSightec at 6 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 9 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
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?
Measures of the clinical success of patients who elect treatment of fibroids are generally subjective, and evaluated by the patient in terms of improvement. (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 9 Jul 2018.