Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00205855 | An Implantable Spinal Cord Stimulation Pain Management System | PHASE3 | COMPLETED | 65 | — | — | Feb 1, 2003 | Mar 1, 2005 | Oct 26, 2012 | 9 | United States |
The VAS score is rated by the patient for the average pain level within the past 7 days where on a scale of 0 to 10, 0 is equal to"no pain" and 10 is equal to "worst pain imaginable." This measurement is captured at baseline and again at 2 weeks post intitial fitting. The measurement is the percent difference between the VAS at 2 weeks post intital fitting from the baseline VAS.
| Arm | Type | Description |
|---|---|---|
| Precision SCS | EXPERIMENTAL | Precision SCS. Patients who receive Precision Spinal Cord Stimulator (SCS) Stimulus system |
| Name | Type | Description |
|---|---|---|
| Precision SCS | DEVICE | Advanced Bionics totally implantable Spinal Cord Stimulation (SCS) System, the Stimulus System. This system is indicated as an aid 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 low back pain and leg pain. |
Inclusion Criteria: 1. Diagnosed with chronic, intractable pain of the trunk and/or limbs which includes but is not limited to, unilateral or bilateral pain associated with any of the following: failed back surgery syndrome, intractable low back pain and leg pain. 2. Be an appropriate candidate for...