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NCT02284542 · ClinicalTrials.gov registry record
NAPS: Non-awake Versus Awake Placement of Spinal Cord Stimulators
A clinical trial, sponsored by St. Luke's Hospital, Pennsylvania.
- Completed
- Registry status
- 34
- Enrollment target
NCT02284542: Completed study, sponsored by St. Luke's Hospital, Pennsylvania.
NCT02284542 is a clinical trial that has completed, run by St. Luke's Hospital, Pennsylvania. The registered enrollment target is 34 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02284542 has completed, sponsored by St. Luke's Hospital, Pennsylvania.
- COMPLETED
- Registry status
- 34 participants
- Enrollment target
Study Summary
The primary objective is to demonstrate the safety and efficacy of a non-awake implantation method (EMG neuromonitoring) of a SCS paddle lead as compared to an awake implantation method (with local anesthesia and patient feedback).This is a post-market, prospective, multicenter, parallel designed, non-randomized, non-blinded, 6-month study. A minimum of 50 patients will be implanted from up to 4 active sites, coordinated by a single lead investigator. Patients who have had a successful SCS trial and are indicated for permanent implantation will be approached to participate in this study prior to permanent implantation. Patients will be recruited and enrolled by physicians at any one of the involved sites. Each Investigator will only use one method (awake or non-awake) according to his/her typical practice. Patients will receive treatment from their enrolling physician.
Interventions
- PROCEDURE Awake
- PROCEDURE Non-Awake
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2014-11-01 |
| Est. Completion | 2017-01-31 |
What the finished NCT02284542 record still lists
NCT02284542 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 34 participants, a relatively small participant target.
The record links to 0 conditions, and to 2 interventions - of which Awake is the first listed.
NCT02284542 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02284542 about?
NCT02284542 is a clinical study titled "NAPS: Non-awake Versus Awake Placement of Spinal Cord Stimulators". The primary objective is to demonstrate the safety and efficacy of a non-awake implantation method (EMG neuromonitoring) of a SCS paddle lead as compared to an awake implantation method (with local anesthesia and patient feedback).This is a post-market, prospective, multicenter, parallel designed, n...
What is the current status of trial NCT02284542?
This trial is currently completed. The enrollment target is 34 participants. The study started on 2014-11-01. Estimated completion is 2017-01-31.
What interventions are being tested in trial NCT02284542?
The interventions under investigation include: Awake (PROCEDURE), Non-Awake (PROCEDURE).
Who is sponsoring clinical trial NCT02284542?
This trial is sponsored by St. Luke's Hospital, Pennsylvania, which has 10 total clinical trials registered on ClinicalTrials.gov.
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