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NCT04319887 · ClinicalTrials.gov registry record · NA
ECAP-controlled, Closed-loop Stimulation to Treat Chronic Trunk and/or Limb Pain (ECAP)
A NA study, sponsored by Saluda Medical Pty.
- Completed
- Registry status
- NA
- Development phase
- 300
- Enrollment target
NCT04319887: Completed NA study, sponsored by Saluda Medical Pty.
NCT04319887 is a NA study that has completed, run by Saluda Medical Pty. The registered enrollment target is 300 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04319887, a NA study, has completed, sponsored by Saluda Medical Pty.
- COMPLETED
- Registry status
- NA
- Development phase
- 300 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate neurophysiological measures and clinical outcomes of the Evoke System to treat trunk and/or limb pain in a real-world population.
Primary Outcome
Dose ratio is determined by the estimated current (mA) at the median ECAP level divided by the current (mA) at the ECAP threshold. The dose ratio allows for both the individualization of a patient's neural dose and comparison across patients, using their ECAP threshold and unique dose response. This metric normalizes for distance between the electrode and the spinal cord and the distances between the stimulation and recording electrodes. The dose ratio reflects the amount of dorsal column activa
Interventions
- DEVICE Evoke Spinal Cord Stimulation (SCS) System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2020-10-29 |
| Est. Completion | 2023-12-28 |
| Phase | NA |
What the finished NCT04319887 record still lists
NCT04319887 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (79% lower).
The record links to 0 conditions, and to 1 intervention - of which Evoke Spinal Cord Stimulation (SCS) System is the first listed.
NCT04319887 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04319887 about?
NCT04319887 is a clinical study titled "ECAP-controlled, Closed-loop Stimulation to Treat Chronic Trunk and/or Limb Pain (ECAP)". The purpose of this study is to evaluate neurophysiological measures and clinical outcomes of the Evoke System to treat trunk and/or limb pain in a real-world population.
What is the current status of trial NCT04319887?
This trial is currently completed. It is a NA study. The enrollment target is 300 participants. The study started on 2020-10-29. Estimated completion is 2023-12-28.
What interventions are being tested in trial NCT04319887?
The interventions under investigation include: Evoke Spinal Cord Stimulation (SCS) System (DEVICE).
Who is sponsoring clinical trial NCT04319887?
This trial is sponsored by Saluda Medical Pty, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04319887's enrollment target sits among peer trials
300 330th of 2000 higher than 1,630 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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