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

Leiomyoma Clinical Trial

— HIFUSB  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03323905
• Other study ID #: HIFUSB
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 16, 2017
• Est. completion date: June 1, 2024

Study information

• Verified date: April 2024
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: June 1, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

10. Waist circumference <110cm or 43 inches

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

Related Conditions & MeSH terms

• Fibroid
• Leiomyoma

Intervention

Device:
• Symphony MRI guided High Intensity Focused Ultrasound (HIFU)
The use of the MRI-HIFU for the ablation of leiomyomas

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	Arrayus Technologies Inc., Sunnybrook Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The ability to ablate fibroid tissue measured by temperature elevation	Measured by MRI thermometry	1 year
Primary	The ability to ablate fibroid tissue indicated by Non-Perfused Volume (NPV)	Measure by contrast enhanced imaging	1 year
Primary	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.	1 year
Primary	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.	1 year
Secondary	Treatment efficacy to reduce fibroid size	Reduction of fibroid volume in milliliters	1 year
Secondary	Treatment efficacy to reduce fibroid size by NPV	Measured by non-perfused volume in milliliters	1 year
Secondary	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.	1 year