Trial Outcomes & Findings for ExAblate Conformal Bone System Treatment of Metastatic Bone Tumors for the Palliation of Pain (NCT NCT00981578)

NCT ID: NCT00981578

Last Updated: 2020-03-11

Results Overview

Adverse effects outcomes are reported in the adverse events module.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 37 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2020-03-11

Participant Flow

The protocol was approved to treat 50 participants at up to six sites. The study was closed by the Sponsor after treating 17 participants at five sites.

Of the 37 subjects enrolled (signed consent), 11 subjects failed additional study requirements and 9 subjects exited the study prior to treatment. Seventeen subjects received the study Exablate treatment.

Participant milestones

Measure	ExAblate 2100 Treatment ExAblate 2100 ablation for the treatment of painful bone metastases. ExAblate 2100: Conformal Bone System
Overall Study STARTED	17
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	ExAblate 2100 Treatment ExAblate 2100 ablation for the treatment of painful bone metastases. ExAblate 2100: Conformal Bone System
Overall Study Death	1
Overall Study Withdrawal by Subject	2

Baseline Characteristics

The baseline characteristics were tabulated for the treated subjects.

Baseline characteristics by cohort

Measure	ExAblate 2100 Treatment n=17 Participants ExAblate 2100 ablation for the treatment of painful bone metastases. ExAblate 2100: Conformal Bone System
Age, Continuous	60.1 years STANDARD_DEVIATION 10.8 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	3 Participants n=5 Participants • The baseline characteristics were tabulated for the treated subjects.
Race/Ethnicity, Customized Black	1 Participants n=5 Participants • The baseline characteristics were tabulated for the treated subjects.
Race/Ethnicity, Customized White	7 Participants n=5 Participants • The baseline characteristics were tabulated for the treated subjects.
Race/Ethnicity, Customized Asian	5 Participants n=5 Participants • The baseline characteristics were tabulated for the treated subjects.
Race/Ethnicity, Customized Pacific Islander	1 Participants n=5 Participants • The baseline characteristics were tabulated for the treated subjects.
Region of Enrollment United States	17 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Adverse effects outcomes are reported in the adverse events module.

Outcome measures

Measure	ExAblate 2100 Treatment n=17 Participants ExAblate 2100 ablation for the treatment of painful bone metastases. ExAblate 2100: Conformal Bone System
Number of Adverse Device Effects	18 Events

SECONDARY outcome

Timeframe: Baseline, 3 months

Efficacy was evaluated by change in Numerical Rating Scale (NRS) pain scores at 3 months post treatment The NRS is an 11 point scale (0-10) with 0 as no pain and 10 as the worst pain. Larger numbers in score change from baseline indicate improvement (decrease) in pain. Two points improvement has been reported as a clinically meaningful.

Outcome measures

Measure	ExAblate 2100 Treatment n=17 Participants ExAblate 2100 ablation for the treatment of painful bone metastases. ExAblate 2100: Conformal Bone System
Change in NRS Pain Scores From Baseline at 3 Months	3.9 Score on a scale Standard Deviation 1.1

SECONDARY outcome

Timeframe: Baseline, 3 months

Quality of life was evaluated using average change from baseline at 3 Months using the Pain Interference section of the Brief Pain Inventory (BPI-Pain Interference). Larger change from Baseline numbers indicate improved function. Pain Interference is the mean of seven questions scored on an 11-point scale of 0 (does not interfere) to 10 (completely interferes). A positive change from Baseline (higher values) at the 3 Month visit indicates improvement or a reduction in pain interference

Outcome measures

Measure	ExAblate 2100 Treatment n=17 Participants ExAblate 2100 ablation for the treatment of painful bone metastases. ExAblate 2100: Conformal Bone System
Change Brief Pain Inventory - Pain Interference From Baseline at 3 Months	3.3 Score on a Scale Standard Deviation 1.9

Adverse Events

ExAblate 2100 Treatment

Serious events: 1 serious events

Other events: 4 other events

Deaths: 1 deaths

Serious adverse events

Measure	ExAblate 2100 Treatment n=17 participants at risk ExAblate 2100 ablation for the treatment of painful bone metastases. ExAblate 2100: Conformal Bone System
Hepatobiliary disorders Cancer Death	5.9% 1/17 • Number of events 1 • 3 Month

Other adverse events

Measure	ExAblate 2100 Treatment n=17 participants at risk ExAblate 2100 ablation for the treatment of painful bone metastases. ExAblate 2100: Conformal Bone System
Injury, poisoning and procedural complications Sonication pain	23.5% 4/17 • Number of events 6 • 3 Month
Injury, poisoning and procedural complications Post-procedure pain / discomfort	5.9% 1/17 • Number of events 1 • 3 Month
Injury, poisoning and procedural complications Skin pain (no redness)	5.9% 1/17 • Number of events 1 • 3 Month
Injury, poisoning and procedural complications Skin burn	5.9% 1/17 • Number of events 1 • 3 Month
Injury, poisoning and procedural complications Bruise at injection site	5.9% 1/17 • Number of events 1 • 3 Month
Injury, poisoning and procedural complications Position pain	5.9% 1/17 • Number of events 1 • 3 Month
General disorders Fatigue	5.9% 1/17 • Number of events 1 • 3 Month
Gastrointestinal disorders Nausea	5.9% 1/17 • Number of events 1 • 3 Month
Renal and urinary disorders Increased creatinine	5.9% 1/17 • Number of events 1 • 3 Month
Injury, poisoning and procedural complications Swelling	5.9% 1/17 • Number of events 1 • 3 Month
Product Issues Unanticipated Effects	0.00% 0/17 • 3 Month

Additional Information

Nadir Alikacem

InSightec

Phone: 214.360.2000

Email: nadira@insightec.com

Results disclosure agreements

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