LeiomyomaHIFUSBNCT03323905
Single Arm Study Using the Symphony -- MRI Guided Focused Ultrasound System for the Treatment of Leiomyomas
A study testing Symphony MRI guided High Intensity Focused Ultrasound (HIFU) in people with Leiomyoma and Fibroid, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
Single arm, first-in human feasibility study using the Symphony - MRI guided focused ultrasound system for the treatment of leiomyomas. The study is expected to accrue over 12 months. This study will help determine the feasibility to ablate leiomyomas, as measured by MR thermometry and contrast enhanced imaging. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- What is being tested?
- Symphony MRI guided High Intensity Focused Ultrasound (HIFU)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 16 Nov 2017to 3 Mar 2024
- 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
- MR-HFU device accessibility to fibroids that at least 50% of fibroid volume can be treated
- Fibroids selected for treatment meet the following criteria
- Total planned ablation volume of all fibroids should not exceed 500 ml AND
- Completely non-enhancing fibroids should not be treated
- Transformed SSS score >= 40
- Pre- or peri-menopausal, as indicated by clinical evaluation
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- Weight < 140 kg or 310 lbs
- Willing and able to attend all study visits
- Willing and able to use reliable contraception methods
- Uterine size < 24 weeks
- Cervical cell assessment by PAP: normal, LOW Grade SIL, Low risk HPV or ASCUS subtypes of cervical tissue
- Waist circumference <110cm or 43 inches
Who cannot join
- Other Pelvic Disease (Other mass, endometriosis, ovarian tumor, acute pelvic disease, significant adenomyosis, prolonged bleeding requiring further evaluation as determined by patient's gynecologist)
- Positive pregnancy test
- Extensive scarring along anterior lower - abdominal wall (>50% of area)
- Surgical clips in the potential path of the HIFU beam
- Tattoos in the potential path of the HIFU beam
- MRI contraindicated
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- MRI contrast agent contraindicated (including renal insufficiency)
- Calcification around or throughout uterine tissue that may affect treatment
- Communication barrier
- Fibroids not quantifiable on MRI (e.g., multi-fibroid cases where volume measurements are not feasible)
- Pedunculated fibroids
- Bowel loops int he ultrasound beam path
- Patients with inability to tolerate prolonged prone position for up to 3 hours
- Patient with unstable medical conditions
- Patients with coagulopathy or under current anti-coagulation therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MRI-guided High Intensity Focused Ultrasound Ablation of Leiomyomas. Single Arm, Feasibility Study Using the Symphony - MRI Guided Focused Ultrasound System for the Treatment of Leiomyomas
Single arm, first-in human feasibility study using the Symphony - MRI guided focused ultrasound system for the treatment of leiomyomas. The study is expected to accrue over 12 months. This study will help determine the feasibility to ablate leiomyomas, as measured by MR thermometry and contrast enhanced imaging. In addition, the study will look at the efficacy and safety of the treatment, as measured by the reduction in fibroid size and reduction in symptom severity score and adverse events. This study will help develop future pivotal trials using the same device.
- Being tested
- Symphony MRI guided High Intensity Focused Ultrasound (HIFU)
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Symphony MRI guided High Intensity Focused Ultrasound (HIFU)Device
The use of the MRI-HIFU for the ablation of leiomyomas
| Study group | Role | What they receive |
|---|---|---|
| MR Guided High Intensity Focused Ultrasound | Experimental | Not described Receives: Device: Symphony MRI guided High Intensity Focused Ultrasound (HIFU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The ability to ablate fibroid tissue measured by temperature elevation
Measured by MRI thermometry
Measured: 1 year
The ability to ablate fibroid tissue indicated by Non-Perfused Volume (NPV)
Measure by contrast enhanced imaging
Measured: 1 year
Safety of the system measured by collection of adverse events related to potential damage to tissue outside the treatment zone
Safety will be measured by collection of adverse events related to potential damage to tissue outside the treatment zone.
Measured: 1 year
Safety of the system based on damage to skin measured by collection of adverse events related to potential damage to skin over the treatment volume
Safety will be measured by collection of adverse events related to potential damage to skin over the treatment volume.
Measured: 1 year
Secondary outcomes (3)
Treatment efficacy to reduce fibroid size
Reduction of fibroid volume in milliliters
Measured: 1 year
Treatment efficacy to reduce fibroid size by NPV
Measured by non-perfused volume in milliliters
Measured: 1 year
Treatment efficacy to reduce symptom severity by Symptom Severity Scores (SSS)
Change in symptoms to be quantified by Symptom Severity Scores (SSS) derived from Uterine Fibroid Symptom and Quality of Life questionnaire.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2017
- Study start16 Nov 2017
- Primary completion1 Dec 2023
- Study completion3 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeiomyomaStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe 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
- Model description
- Pilot single arm feasibility trial.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Sunnybrook Research Institute, Arrayus Technologies Inc.
- Responsible party
- Principal investigator, Dr. Elizabeth David, Sunnybrook Health Sciences Centre
- Investigators
- David Elizabeth, Principal investigator, Sunnybrook Reserach Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03323905
- Sponsor's protocol ID
- HIFUSB
- Acronym
- HIFUSB
- Status last verified
- Jul 2024
- First submitted
- 22 Sep 2017
- Last updated
- 9 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI-guided High Intensity Focused Ultrasound Ablation of Leiomyomas. Single Arm, Feasibility Study Using the Symphony - MRI Guided Focused Ultrasound System for the Treatment of Leiomyomas
- ClinicalTrials.gov ID
- NCT03323905
- Acronym / sponsor ID
- HIFUSB / HIFUSB
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Sunnybrook Research Institute, Arrayus Technologies Inc.
- Study start
- 16 Nov 2017 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 3 Mar 2024 (actual)
- First posted
- 27 Oct 2017 (actual)
- 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.
Single arm, first-in human feasibility study using the Symphony - MRI guided focused ultrasound system for the treatment of leiomyomas. The study is expected to accrue over 12 months. This study will help determine the feasibility to ablate leiomyomas, as measured by MR thermometry and contrast enhanced imaging. In addition, the study will look at the efficacy and safety of the treatment, as measured by the reduction in fibroid size and reduction in symptom severity score and adverse events. This study will help develop future pivotal trials using the same device.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot single arm feasibility trial.
| Arm | Type | Receives |
|---|---|---|
| MR Guided High Intensity Focused Ultrasound | Experimental | Device: Symphony MRI guided High Intensity Focused Ultrasound (HIFU) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- MR-HFU device accessibility to fibroids that at least 50% of fibroid volume can be treated
- Fibroids selected for treatment meet the following criteria
- Transformed SSS score >= 40
- Pre- or peri-menopausal, as indicated by clinical evaluation
- Weight < 140 kg or 310 lbs
Key exclusion criteria (15 listed)
- Other Pelvic Disease (Other mass, endometriosis, ovarian tumor, acute pelvic disease, significant adenomyosis, prolonged bleeding requiring further evaluation as determined by patient's gynecologist)
- Positive pregnancy test
- Extensive scarring along anterior lower - abdominal wall (>50% of area)
- Surgical clips in the potential path of the HIFU beam
- Tattoos in the potential path of the HIFU beam
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 |
|---|---|---|
| Symphony MRI guided High Intensity Focused Ultrasound (HIFU)The use of the MRI-HIFU for the ablation of leiomyomas | Device | MR Guided High Intensity Focused Ultrasound |
Primary outcome
The ability to ablate fibroid tissue measured by temperature elevation
Time frame: 1 year
Measured by MRI thermometry
The ability to ablate fibroid tissue indicated by Non-Perfused Volume (NPV)
Time frame: 1 year
Measure by contrast enhanced imaging
Safety of the system measured by collection of adverse events related to potential damage to tissue outside the treatment zone
Time frame: 1 year
Safety will be measured by collection of adverse events related to potential damage to tissue outside the treatment zone.
Safety of the system based on damage to skin measured by collection of adverse events related to potential damage to skin over the treatment volume
Time frame: 1 year
Safety will be measured by collection of adverse events related to potential damage to skin over the treatment volume.
3 secondary outcomes
Treatment efficacy to reduce fibroid size
Time frame: 1 year
Treatment efficacy to reduce fibroid size by NPV
Time frame: 1 year
Treatment efficacy to reduce symptom severity by Symptom Severity Scores (SSS)
Time frame: 1 year
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 2024.
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Predictors of Success and Failure of v-NOTES Hysterectomy for Large and Very Large Uteri
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Hereditary Leiomyomatosis Renal Cell Cancer - Study of the Genetic Cause and the Predisposition to Renal Cancer
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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.
David Elizabeth principal investigator
Sunnybrook Reserach Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Symphony MRI guided High Intensity Focused Ultrasound (HIFU) in people with Leiomyoma and Fibroid, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
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 12 inclusion and 15 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 2024. 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 Canada. 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?
The ability to ablate fibroid tissue measured by temperature elevation (time frame: 1 year). The study lists 4 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 9 Jul 2024.