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NCT02800863 · ClinicalTrials.gov registry record
TARGET Post-Approval Study
A clinical trial, sponsored by Abbott Medical Devices.
- Completed
- Registry status
- 426
- Enrollment target
NCT02800863: Completed study, sponsored by Abbott Medical Devices.
NCT02800863 is a clinical trial that has completed, run by Abbott Medical Devices. The registered enrollment target is 426 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02800863 has completed, sponsored by Abbott Medical Devices.
- COMPLETED
- Registry status
- 426 participants
- Enrollment target
Study Summary
The purpose of this prospective, multicenter, single arm post-approval study is to demonstrate continued safety of the Axium and Proclaim Neurostimulator System for dorsal root ganglion (DRG) stimulation. The primary endpoint is the 12-month serious adverse event rate for permanent implants.
Primary Outcome
The serious adverse event rate for subjects receiving the permanent DRG implantable pulse generator (IPG) was analyzed using Kaplan-Meier method on subjects who received the permanent Axium or Proclaim DRG IPG (N = 296). While 426 patients were enrolled, only 296 received the permanent implant. The primary population is 296.
Interventions
- DEVICE Dorsal Root Ganglion (DRG) Stimulation (Axium™ Neurostimulator System)
- DEVICE Dorsal Root Ganglion (DRG) Stimulation (Proclaim™ Neurostimulator System)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 426 participants |
| Start Date | 2016-08-23 |
| Est. Completion | 2021-09-23 |
What the finished NCT02800863 record still lists
NCT02800863 is an observational study that tracks outcomes without assigning an intervention. The registered 426 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 2 interventions - of which Dorsal Root Ganglion (DRG) Stimulation (Axium™ Neurostimulator System) is the first listed.
NCT02800863 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02800863 about?
NCT02800863 is a clinical study titled "TARGET Post-Approval Study". The purpose of this prospective, multicenter, single arm post-approval study is to demonstrate continued safety of the Axium and Proclaim Neurostimulator System for dorsal root ganglion (DRG) stimulation. The primary endpoint is the 12-month serious adverse event rate for permanent implants.
What is the current status of trial NCT02800863?
This trial is currently completed. The enrollment target is 426 participants. The study started on 2016-08-23. Estimated completion is 2021-09-23.
What interventions are being tested in trial NCT02800863?
The interventions under investigation include: Dorsal Root Ganglion (DRG) Stimulation (Axium™ Neurostimulator System) (DEVICE), Dorsal Root Ganglion (DRG) Stimulation (Proclaim™ Neurostimulator System) (DEVICE).
Who is sponsoring clinical trial NCT02800863?
This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.
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