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
| 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
| 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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place