Trial Outcomes & Findings for MR Guided Focused Ultrasound Treatment of Uterine Fibroids With Enhanced Sonication (NCT NCT00365989)

NCT ID: NCT00365989

Last Updated: 2019-02-05

Results Overview

The study objective is to determine the safety of the new Enhanced Sonication technique and assure no new safety issues are introduced.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 50 participants
• Primary outcome timeframe: Within 1 month of treatment
• Results posted on: 2019-02-05

Participant Flow

Out of the 83 subjects signing consent, 33 subjects failed additional study requirements and did not participate. Fifty (50) subjects were treated; 48 received enhanced sonications, 2 received only nominal sonications.

Participant milestones

Measure	Enhanced Sonication Test Arm ExAblate 2000 Enhanced Sonication (ES) mode generates higher ultrasound energy absorption at the focal volume compared to normal sonications.
Overall Study STARTED	50
Overall Study COMPLETED	48
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Enhanced Sonication Test Arm ExAblate 2000 Enhanced Sonication (ES) mode generates higher ultrasound energy absorption at the focal volume compared to normal sonications.
Overall Study Withdrawal by Subject	1
Overall Study Non-compliance	1

Baseline Characteristics

MR Guided Focused Ultrasound Treatment of Uterine Fibroids With Enhanced Sonication

Baseline characteristics by cohort

Measure	Enhanced Sonication Test Arm n=48 Participants ExAblate 2000 Enhanced Sonication (ES) mode generates higher ultrasound energy absorption at the focal volume compared to normal sonications.
Age, Continuous	45 years STANDARD_DEVIATION 5.4 • n=93 Participants
Sex: Female, Male Female	48 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	5 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	3 Participants n=93 Participants
Race (NIH/OMB) White	40 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment Canada	11 participants n=93 Participants
Region of Enrollment United States	37 participants n=93 Participants

PRIMARY outcome

Timeframe: Within 1 month of treatment

The study objective is to determine the safety of the new Enhanced Sonication technique and assure no new safety issues are introduced.

Outcome measures

Measure	Enhanced Sonication Test Arm n=48 Participants ExAblate 2000 Enhanced Sonication (ES) mode generates higher ultrasound energy absorption at the focal volume compared to normal sonications.
Number of Adverse Events Total Adverse Events	77 Adverse Events
Number of Adverse Events Mild/Moderate Adverse Events	75 Adverse Events

OTHER_PRE_SPECIFIED outcome

Timeframe: During treatment

Population: Of the 50 subjects treated, 39 were included in the thermal analysis per the protocol. Of the 11 subjects not eligible, 8 were not treated with at least 30% enhanced sonications. Three subjects received enhanced sonications at tissue depths greater that 70 mm from the skin line.

The secondary end point of the study is to evaluate the mean normalized Enhanced Sonication thermal dose volume. Normalized dose volume is a function of the sonication dose volume divided by the energy transmitted measured from the the MR thermometry imaging.

Outcome measures

Measure	Enhanced Sonication Test Arm n=39 Participants ExAblate 2000 Enhanced Sonication (ES) mode generates higher ultrasound energy absorption at the focal volume compared to normal sonications.
Mean Enhanced Sonication Normalized Thermal Dose Volume	0.67 cc/KJ/sonication Standard Deviation 0.35

OTHER_PRE_SPECIFIED outcome

Timeframe: Within 1 month of treatment

Outcome measures

Measure	Enhanced Sonication Test Arm n=48 Participants ExAblate 2000 Enhanced Sonication (ES) mode generates higher ultrasound energy absorption at the focal volume compared to normal sonications.
Number of Participants With Adverse Events Subjects reporting AEs	35 Participants
Number of Participants With Adverse Events Subjects with SAE reported	0 Participants
Number of Participants With Adverse Events Subjects with no AEs reported	13 Participants
Number of Participants With Adverse Events Subject deaths	0 Participants

Adverse Events

Enhanced Sonication Test Arm

Serious events: 0 serious events

Other events: 35 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Enhanced Sonication Test Arm n=48 participants at risk ExAblate 2000 Enhanced Sonication (ES) mode generates higher ultrasound energy absorption at the focal volume compared to normal sonications.
General disorders All Pain/Discomfort	66.7% 32/48
Renal and urinary disorders Urinary tract infection	10.4% 5/48
Gastrointestinal disorders Gastrointestinal	10.4% 5/48
Reproductive system and breast disorders Abnormal Vaginal Discharge	100.0% 2/2
Skin and subcutaneous tissue disorders Skin burn	2.1% 1/48
General disorders Fever	2.1% 1/48
Vascular disorders Thrombophlebitis	2.1% 1/48
Nervous system disorders Migraine	2.1% 1/48
General disorders Dental	2.1% 1/48
General disorders Dizziness	2.1% 1/48
Skin and subcutaneous tissue disorders Edema	2.1% 1/48
Skin and subcutaneous tissue disorders IV bruise/numbness	2.1% 1/48
Skin and subcutaneous tissue disorders Rash	2.1% 1/48
Reproductive system and breast disorders Heavy menses	2.1% 1/48
Reproductive system and breast disorders Abdominal cramping	2.1% 1/48
Surgical and medical procedures Leg pain - sonication related	27.1% 13/48
Surgical and medical procedures Abdominal pain - sonication related	14.6% 7/48
Surgical and medical procedures Back pain - sonication related	14.6% 7/48
Surgical and medical procedures Skin pain - sonication related	12.5% 6/48
Surgical and medical procedures Pain - sonication related	4.2% 2/48
Renal and urinary disorders Urinary frequency	2.1% 1/48
Renal and urinary disorders Dysuria	2.1% 1/48
Renal and urinary disorders Incontinence	2.1% 1/48

Additional Information

Nadir Alikacem

InSightec

Phone: 214-630-2000

Email: nadira@insightec.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place