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

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ClinicalTrials.gov Identifier: NCT03323905
Recruitment Status : Active, not recruiting
First Posted : October 27, 2017
Last Update Posted : October 31, 2018
Sponsor:
Collaborators:
Sunnybrook Research Institute
Harmonics Medical Inc.
Information provided by (Responsible Party):
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

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 [ Time Frame: 1 year ]
    Measured by MR thermometry

  2. The ability to ablate fibroid tissue [ Time Frame: 1 year ]
    Measure by contrast enhanced imaging

  3. Incidence of Treatment-Emergent Adverse Events [ Time Frame: 1 year ]
    Safety will be measured by collection of adverse events


Secondary Outcome Measures :
  1. Treatment effectiveness to reduce fibroid size. [ Time Frame: 1 year ]
    Efficacy will be measured by the reduction in fibroid size based on MR contrast enhanced imaging.

  2. Incidence of treatment-emerging AEs (safety) [ Time Frame: 1 year ]
    Symptom severity score will be measured based on adverse events

  3. Confirmation of intended fibroid treatment [ Time Frame: 1 year ]
    Technical effectiveness through the use of MR thermometry and NPV data. Determine if the fibroid was treated and if any area outside the fibroid was compromised



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • Pre- or per-menopausal, as indicated by clinical evaluation
  • 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
  • Women with no interest in preserving future fertility

Exclusion Criteria:

  • 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 int he potential path of the HIFU beam
  • MRI contraindicated
  • 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
  • Patient with inability to tolerate prolonged prone position for up to 3 hours
  • Patient with unstable medical conditions
  • Patients with coagulopathy or under current anticoagulation 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


Locations
Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Sunnybrook Research Institute
Harmonics Medical Inc.
Investigators
Principal Investigator: David Elizabeth Sunnybrook Reserach Institute

Responsible Party: Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT03323905     History of Changes
Other Study ID Numbers: HIFUSB
First Posted: October 27, 2017    Key Record Dates
Last Update Posted: October 31, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases