Trial Outcomes & Findings for Magnetic Resonance (MR) Guided Focused Ultrasound Surgery of Uterine Fibroids (NCT NCT00131365)

NCT ID: NCT00131365

Last Updated: 2019-06-12

Results Overview

Adverse events outcomes are reported in the adverse events module.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 9 participants
• Primary outcome timeframe: 36 months
• Results posted on: 2019-06-12

Participant Flow

The protocol was approved to enroll 20 participants; however, due to the obsolescence of device features the study was closed after enrolling 9 participants.

Participant milestones

Measure	ExAblate MRgFUS Treatment with the ExAblate 2000 system Version 4.1
Overall Study STARTED	9
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	ExAblate MRgFUS Treatment with the ExAblate 2000 system Version 4.1
Overall Study Withdrawal by Subject	1
Overall Study Alternative treatment	3

Baseline Characteristics

Magnetic Resonance (MR) Guided Focused Ultrasound Surgery of Uterine Fibroids

Baseline characteristics by cohort

Measure	ExAblate MRgFUS n=9 Participants Treatment with the ExAblate 2000 system Version 4.1
Age, Customized not collected	NA Participants n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 36 months

Population: Adverse events outcomes are reported in the adverse events module.

Adverse events outcomes are reported in the adverse events module.

Outcome measures

Measure	ExAblate MRgFUS n=9 Participants Treatment with the ExAblate 2000 system Version 4.1 ExAblate 2000
Number and Type of Adverse Events	15 Adverse Events

POST_HOC outcome

Timeframe: 36 months

Adverse events outcomes are reported in the adverse events module.

Outcome measures

Measure	ExAblate MRgFUS n=9 Participants Treatment with the ExAblate 2000 system Version 4.1 ExAblate 2000
Number of Subjects With Adverse Events	6 Participants

Adverse Events

ExAblate MRgFUS

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	ExAblate MRgFUS n=9 participants at risk Treatment with the ExAblate 2000 system Version 4.1 ExAblate 2000
Surgical and medical procedures Abdominal pain	22.2% 2/9 • Number of events 2 • 36 months
Surgical and medical procedures Discomfort	22.2% 2/9 • Number of events 2 • 36 months
Surgical and medical procedures Back pain - positional	11.1% 1/9 • Number of events 1 • 36 months
Surgical and medical procedures Leg/back pain - sonication induced	11.1% 1/9 • Number of events 1 • 36 months
Surgical and medical procedures Neck pain	11.1% 1/9 • Number of events 1 • 36 months
Surgical and medical procedures Abdominal pain - sonication related	11.1% 1/9 • Number of events 1 • 36 months
Renal and urinary disorders Hematuria	11.1% 1/9 • Number of events 1 • 36 months
Renal and urinary disorders Urinary tract infection	11.1% 1/9 • Number of events 1 • 36 months
Renal and urinary disorders Foley catheter urethral irritation	11.1% 1/9 • Number of events 1 • 36 months
Gastrointestinal disorders Hematochezia	22.2% 2/9 • Number of events 2 • 36 months
Gastrointestinal disorders Anal irritation	11.1% 1/9 • Number of events 1 • 36 months
Nervous system disorders Transient Dysaesthesia	11.1% 1/9 • Number of events 1 • 36 months

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