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Single Arm Study Using the Symphony -- MRI Guided Focused Ultrasound System for the Treatment of Leiomyomas (HIFUSB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03323905
Recruitment Status : Recruiting
First Posted : October 27, 2017
Last Update Posted : September 4, 2019
Sponsor:
Collaborators:
Sunnybrook Research Institute
Harmonic Medical Inc.
Information provided by (Responsible Party):
Dr. Elizabeth David, Sunnybrook Health Sciences Centre

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Leiomyoma Fibroid Device: Symphony MRI guided High Intensity Focused Ultrasound (HIFU) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Pilot single arm feasibility trial.
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : November 16, 2017
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Experimental: MR Guided High Intensity Focused Ultrasound Device: Symphony MRI guided High Intensity Focused Ultrasound (HIFU)
The use of the MRI-HIFU for the ablation of leiomyomas




Primary Outcome Measures :
  1. The ability to ablate fibroid tissue measured by temperature elevation [ Time Frame: 1 year ]
    Measured by MRI thermometry

  2. The ability to ablate fibroid tissue indicated by Non-Perfused Volume (NPV) [ Time Frame: 1 year ]
    Measure by contrast enhanced imaging

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. Treatment efficacy to reduce fibroid size [ Time Frame: 1 year ]
    Reduction of fibroid volume in milliliters

  2. Treatment efficacy to reduce fibroid size by NPV [ Time Frame: 1 year ]
    Measured by non-perfused volume in milliliters

  3. Treatment efficacy to reduce symptom severity by Symptom Severity Scores (SSS) [ Time Frame: 1 year ]
    Change in symptoms to be quantified by Symptom Severity Scores (SSS) derived from Uterine Fibroid Symptom and Quality of Life questionnaire.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. MR-HFU device accessibility to fibroids that at least 50% of fibroid volume can be treated
  2. Fibroids selected for treatment meet the following criteria

    1. Total planned ablation volume of all fibroids should not exceed 500 ml AND
    2. Completely non-enhancing fibroids should not be treated
  3. Transformed SSS score >= 40
  4. Pre- or peri-menopausal, as indicated by clinical evaluation
  5. Weight < 140 kg or 310 lbs
  6. Willing and able to attend all study visits
  7. Willing and able to use reliable contraception methods
  8. Uterine size < 24 weeks
  9. Cervical cell assessment by PAP: normal, LOW Grade SIL, Low risk HPV or ASCUS subtypes of cervical tissue

Exclusion Criteria:

  1. Other Pelvic Disease (Other mass, endometriosis, ovarian tumor, acute pelvic disease, significant adenomyosis, prolonged bleeding requiring further evaluation as determined by patient's gynecologist)
  2. Positive pregnancy test
  3. Extensive scarring along anterior lower - abdominal wall (>50% of area)
  4. Surgical clips in the potential path of the HIFU beam
  5. Tattoos in the potential path of the HIFU beam
  6. MRI contraindicated
  7. MRI contrast agent contraindicated (including renal insufficiency)
  8. Calcification around or throughout uterine tissue that may affect treatment
  9. Communication barrier
  10. Fibroids not quantifiable on MRI (e.g., multi-fibroid cases where volume measurements are not feasible)
  11. Pedunculated fibroids
  12. Bowel loops int he ultrasound beam path
  13. Patients with inability to tolerate prolonged prone position for up to 3 hours
  14. Patient with unstable medical conditions
  15. Patients with coagulopathy or under current anti-coagulation therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03323905


Contacts
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Contact: Harley Meirovich 4164806100 ext 5790 hifu.fibroids@sunnybrook.ca

Locations
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Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N3M5
Contact: Harley Meirovich    4164806100 ext 5790    harley.meirovich@sri.utoronto.ca   
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Sunnybrook Research Institute
Harmonic Medical Inc.
Investigators
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Principal Investigator: David Elizabeth Sunnybrook Reserach Institute

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Responsible Party: Dr. Elizabeth David, Affiliate scientist, Interventional Radiologist and Assistant Professor, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT03323905    
Other Study ID Numbers: HIFUSB
First Posted: October 27, 2017    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases