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NCT02989610 · ClinicalTrials.gov registry record
Clinical Evaluation of the Infinity Deep Brain Stimulation System
A clinical trial, sponsored by Abbott Medical Devices.
- Completed
- Registry status
- 234
- Enrollment target
NCT02989610: Completed study, sponsored by Abbott Medical Devices.
NCT02989610 is a clinical trial that has completed, run by Abbott Medical Devices. The registered enrollment target is 234 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02989610 has completed, sponsored by Abbott Medical Devices.
- COMPLETED
- Registry status
- 234 participants
- Enrollment target
Study Summary
The purpose of this post-market study is to characterize the clinical performance of the Infinity Deep Brain Stimulation (DBS) system, including the Implantable Pulse Generator (IPG), directional DBS leads, extensions, iPad clinician programmer, iPod patient controller and related system components. Participants in the PROGRESS study are not assigned to interventional therapy groups. Participants in the PROGRESS study are followed in an observational format as they receive omnidirectional and then directional DBS programming that is part of routine medical care. Data on symptoms are collected during two different stages of programming, and those outcomes compared to assess the effect of omnidirectional or directional programming.
Primary Outcome
Therapeutic window is the range of stimulation amplitude that produces symptom relief without causing side effects. Proportion of subjects with a wider therapeutic window using directional stimulation, compared to a threshold of 60%. Based on randomized, double-blind evaluation using within-subject control.
Interventions
- DEVICE Omnidirectional stimulation
- DEVICE Directional stimulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 234 participants |
| Start Date | 2017-01-31 |
| Est. Completion | 2022-04-19 |
What the finished NCT02989610 record still lists
NCT02989610 is an observational study that tracks outcomes without assigning an intervention. The registered 234 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 2 interventions - of which Omnidirectional stimulation is the first listed.
NCT02989610 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02989610 about?
NCT02989610 is a clinical study titled "Clinical Evaluation of the Infinity Deep Brain Stimulation System". The purpose of this post-market study is to characterize the clinical performance of the Infinity Deep Brain Stimulation (DBS) system, including the Implantable Pulse Generator (IPG), directional DBS leads, extensions, iPad clinician programmer, iPod patient controller and related system components....
What is the current status of trial NCT02989610?
This trial is currently completed. The enrollment target is 234 participants. The study started on 2017-01-31. Estimated completion is 2022-04-19.
What interventions are being tested in trial NCT02989610?
The interventions under investigation include: Omnidirectional stimulation (DEVICE), Directional stimulation (DEVICE).
Who is sponsoring clinical trial NCT02989610?
This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.
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