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

NCT ID: NCT03323905

Last Updated: 2024-07-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-16
• Study Completion Date: 2024-03-03

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.

Conditions

Leiomyoma; Fibroid

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MR Guided High Intensity Focused Ultrasound

Group Type: EXPERIMENTAL

Symphony MRI guided High Intensity Focused Ultrasound (HIFU)

Intervention Type: DEVICE

The use of the MRI-HIFU for the ablation of leiomyomas

Interventions

Symphony MRI guided High Intensity Focused Ultrasound (HIFU)

The use of the MRI-HIFU for the ablation of leiomyomas

Intervention Type: DEVICE

Eligibility 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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Sunnybrook Research Institute

OTHER

Sponsor Role: collaborator

Arrayus Technologies Inc.

INDUSTRY

Sponsor Role: collaborator

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: lead

Responsible Party

Dr. Elizabeth David

Affiliate scientist, Interventional Radiologist and Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Elizabeth

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Reserach Institute

Locations

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

HIFUSB

Identifier Type: -

Identifier Source: org_study_id