Uterine FibroidsNCT01328067
Study to Evaluate the Safety and Effectiveness of MRgFUS Compared With Myomectomy for the Treatment of Uterine Fibroids
A study testing Exablate 2100 and Myomectomy in people with Uterine Fibroids and Bleeding, run by InSightec at 1 site in United Kingdom.
Trial summary
The objective of this trial is to evaluate the safety and efficacy of ExAblate for the treatment of uterine fibroids. Women, seeking treatment for symptomatic uterine leiomyomata will be eligible for the study.Women who agree to participate will sign an informed consent and will be randomized to ExAblate treatment or… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Uterine Fibroids, Bleeding, Pelvic Pain
- What is being tested?
- Exablate 2100 and Myomectomy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2011to Jun 2017
- 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 to 50 years
- Women only
- No healthy volunteers
- 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 (raw score) 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)
- Able to communicate sensations during the ExAblate procedure
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- Uterine fibroids, which are device accessible
- Fibroid(s) clearly visible on non-contrast MRI.
- Fibroid(s) enhances on MR contrast imaging
Who cannot join
- Women currently pregnant
- Uterine size > 24 cm W/O the cervix
- More than 4 clinically significant fibroids (per MRI)
- Prior myomectomy, UAE
- Allergy to either gadolinium or iodinated contrast
- Implanted metallic device prohibiting MRI
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- Severe claustrophobia
- Active pelvic infection
- Current use of intrauterine contraceptive device
- Unstable medical conditions requiring additional monitoring during the procedure
- Bleeding diathesis requiring medical treatment
- Imaging suggestive of malignant disease of uterus, ovary, or cervix
- Imaging and suggestive of adenomyosis.
- Pedunculated submucosal or pedunculated subserosal myoma
- Size and weight which prohibits subject from fitting in MRI device
- Unavoidable, scarring, skin folds or irregularity, bowel, pubic bone, IUD, surgical clips or hard implants in the beam path.
- Hyper intense fibroid relatively to the uterus muscle
- Women with ovarian dermoid cyst anywhere in the treatment path
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Study to Evaluate the Safety and Effectiveness of MRgFUS Procedure Compared With Myomectomy for the Treatment of Uterine Fibroids
The objective of this trial is to evaluate the safety and efficacy of ExAblate for the treatment of uterine fibroids.
Women, seeking treatment for symptomatic uterine leiomyomata will be eligible for the study.Women who agree to participate will sign an informed consent and will be randomized to ExAblate treatment or myomectomy.
All patients will be followed through the 36 month visit. Follow-up visits/telephone calls will be completed at 1 week, 2 weeks, 6 weeks, 3 months, 6, 12, 18, 24 and 36 months post treatment.
Patients will be evaluated by assessing their overall physical and mental health as well as for device/procedure related adverse events.
- Conditions
- Uterine Fibroids, Bleeding, Pelvic Pain
- Being tested
- Exablate 2100, Myomectomy
- Keywords
- MRgFus, Uterine Fibroids, Pelvic Pain, Quality of Life, Symptomatic Uterine Fibroids
- Medical subject headings
- Leiomyoma, Hemorrhage, Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exablate 2100Device
MRgFUS
MyomectomyProcedure or surgery
Non-Hysteroscopic Myomectomy
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Active comparator | MR guided Focused Ultrasound Receives: Device: Exablate 2100 |
| Surgery | Active comparator | Myomectomy Receives: Procedure: Myomectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Safety will be evaluated by recording and assessing the incidence and severity of major adverse events from treatment through the 3 years follow-up period.
Measured: 36 months post treatment
Efficacy
Comparison between ExAblate treatment and non-Hysteroscopic Myomectomy in terms of treated patients who did not undergo another interventional treatment for recurrence of uterine fibroid symptoms at up to 36 months (3 years).
Measured: 36 months post treatment
Secondary outcomes (1)
Efficacy
- Post treatment change in patient's quality of life
- Post treatment change in pelvic pain
- Post treatment Change in bleeding
- Post treatment recovery time
Measured: 36 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2011 (estimated)
- Study startJun 2011
- Primary completionJan 2017
- Study completionJun 2017
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- InSightec
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wady Gedroyc, Prof., Principal investigator, St Mary's Hospital, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01328067
- Sponsor's protocol ID
- UF034
- Status last verified
- Jun 2018
- First submitted
- 31 Mar 2011
- Last updated
- 15 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study to Evaluate the Safety and Effectiveness of MRgFUS Procedure Compared With Myomectomy for the Treatment of Uterine Fibroids
- ClinicalTrials.gov ID
- NCT01328067
- Acronym / sponsor ID
- UF034
- Conditions
- Uterine Fibroids, Bleeding, Pelvic Pain
- Keywords
- MRgFus, Uterine Fibroids, Pelvic Pain, Quality of Life, Symptomatic Uterine Fibroids
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- InSightecIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 4 Apr 2011 (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.
The objective of this trial is to evaluate the safety and efficacy of ExAblate for the treatment of uterine fibroids.
Women, seeking treatment for symptomatic uterine leiomyomata will be eligible for the study.Women who agree to participate will sign an informed consent and will be randomized to ExAblate treatment or myomectomy.
All patients will be followed through the 36 month visit. Follow-up visits/telephone calls will be completed at 1 week, 2 weeks, 6 weeks, 3 months, 6, 12, 18, 24 and 36 months post treatment.
Patients will be evaluated by assessing their overall physical and mental health as well as for device/procedure related adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Active comparator | Device: Exablate 2100MR guided Focused Ultrasound |
| Surgery | Active comparator | Procedure: MyomectomyMyomectomy |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 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 (raw score) 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 currently pregnant
- Uterine size > 24 cm W/O the cervix
- More than 4 clinically significant fibroids (per MRI)
- Prior myomectomy, UAE
- Allergy to either gadolinium or iodinated contrast
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 2100MRgFUS | Device | Treatment |
| MyomectomyNon-Hysteroscopic Myomectomy | Procedure or surgery | Surgery |
Primary outcome
Safety
Time frame: 36 months post treatment
Safety will be evaluated by recording and assessing the incidence and severity of major adverse events from treatment through the 3 years follow-up period.
Efficacy
Time frame: 36 months post treatment
Comparison between ExAblate treatment and non-Hysteroscopic Myomectomy in terms of treated patients who did not undergo another interventional treatment for recurrence of uterine fibroid symptoms at up to 36 months (3 years).
1 secondary outcome
Efficacy
Time frame: 36 months post treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2018.
- Sponsor's websiteLink 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.
Wady Gedroyc, Prof. principal investigator
St Mary's Hospital, London
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 2100 and Myomectomy in people with Uterine Fibroids and Bleeding, run by InSightec at 1 site in United Kingdom.
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 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: withdrawn, as of the sponsor's last update on 15 Jun 2018. 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 Kingdom. 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 was withdrawn before enrolling participants, so there are no results.
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?
Safety (time frame: 36 months post treatment). The study lists 2 primary outcomes in all. 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 15 Jun 2018.