Trial Outcomes & Findings for Effectiveness of Precision Spinal Cord Stimulation With Artisan Paddle Electrode (NCT NCT00386724)

Results Overview

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

8 participants

Primary outcome timeframe

3 months post-activation

Results posted on

2020-12-17

Participant milestones
Measure	Precision Spinal Cord Stimulation Single arm Precision Spinal Cord Stimulation System with Artisan Surgical Lead Precision Spinal Cord Stimulation System: Precision System aids in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable back pain, and leg pain. Artisan Surgical Lead: Artisan paddle electrode is a 2 x 8 surgical lead approved for use as part of the Precision System.
Overall Study STARTED	8
Overall Study 3 Months Post-activation	4
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	5

Withdrawal data not reported

Effectiveness of Precision Spinal Cord Stimulation With Artisan Paddle Electrode

Baseline characteristics by cohort
Measure	Precision Spinal Cord Stimulation n=8 Participants Single arm Precision Spinal Cord Stimulation System with Artisan Surgical Lead Precision Spinal Cord Stimulation System: Precision System aids in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable back pain, and leg pain. Artisan Surgical Lead: Artisan paddle electrode is a 2 x 8 surgical lead approved for use as part of the Precision System.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants

Timeframe: 3 months post-activation

Population: The study was terminated and efforts were made to locate data. No study data are available.

Outcome data not reported

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Precision Spinal Cord Stimulation n=8 participants at risk Single arm Precision Spinal Cord Stimulation System with Artisan Surgical Lead Precision Spinal Cord Stimulation System: Precision System aids in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable back pain, and leg pain. Artisan Surgical Lead: Artisan paddle electrode is a 2 x 8 surgical lead approved for use as part of the Precision System.
Musculoskeletal and connective tissue disorders Shoulder pain	12.5% 1/8 • Number of events 1 • Adverse events were collected from enrollment through completion of study data collection (12 months post-activation or withdrawal)

Boston Scientific

Phone: 6619494350