Status:
COMPLETED
Single Arm Study Using the Symphony -- MRI Guided Focused Ultrasound System for the Treatment of Leiomyomas
Lead Sponsor:
Sunnybrook Health Sciences Centre
Collaborating Sponsors:
Sunnybrook Research Institute
Arrayus Technologies Inc.
Conditions:
Leiomyoma
Fibroid
Eligibility:
FEMALE
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
November 16 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 3 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03323905
Start Date
November 16 2017
End Date
March 3 2024
Last Update
July 9 2024
Active Locations (1)
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1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N3M5