Trial Outcomes & Findings for Efficacy of the Spinal Cord Stimulation System as Salvage Therapy (NCT NCT00387244)

NCT ID: NCT00387244

Last Updated: 2020-12-17

Results Overview

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

7 participants

Primary outcome timeframe

Baseline and at End of trial (approximately 5 days)

Results posted on

2020-12-17

Participant Flow

Participant milestones

Participant milestones
Measure
Precision for Spinal Cord Stimulation
Single arm Precision for Spinal Cord Stimulation Precision for Spinal Cord Stimulation: 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.
Overall Study
STARTED
7
Overall Study
End of Trial
0
Overall Study
COMPLETED
0
Overall Study
NOT COMPLETED
7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy of the Spinal Cord Stimulation System as Salvage Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Precision for Spinal Cord Stimulation
n=7 Participants
Single arm Precision for Spinal Cord Stimulation Precision for Spinal Cord Stimulation: 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.
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
4 Participants
n=5 Participants
Age, Categorical
>=65 years
3 Participants
n=5 Participants
Sex: Female, Male
Female
4 Participants
n=5 Participants
Sex: Female, Male
Male
3 Participants
n=5 Participants

PRIMARY outcome

Timeframe: Baseline and at End of trial (approximately 5 days)

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

Outcome measures

Outcome data not reported

Adverse Events

Precision for Spinal Cord Stimulation

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Director, Clinical Research Sciences

Boston Scientific

Phone: 6619494350

Results disclosure agreements

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