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NCT03594266 · ClinicalTrials.gov registry record · NA
Comparison of the Effects of Two Spinal Cord Stimulation (SCS) Therapies on Subject Reported Pain (BENEFIT-02)
A NA study, sponsored by Biotronik.
- Completed
- Registry status
- NA
- Development phase
- 136
- Enrollment target
NCT03594266: Completed NA study, sponsored by Biotronik.
NCT03594266 is a NA study that has completed, run by Biotronik. The registered enrollment target is 136 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03594266, a NA study, has completed, sponsored by Biotronik.
- COMPLETED
- Registry status
- NA
- Development phase
- 136 participants
- Enrollment target
Study Summary
A BIOTRONIK wearable stimulator will be utilized in order to investigate the effects of two study spinal cord stimulation (SCS) therapies on subject reported pain and paresthesia perception observed over 12 days of study stimulation testing following the conclusion of a successful SCS commercial trial.
Primary Outcome
The purpose of primary endpoint 1 is to evaluate the change since baseline in Numerical Rating Scale (NRS) for pain (overall) for each study SCS therapy. The evaluation of primary endpoint 1 is based on the NRS for pain (overall) obtained at the final study testing visit compared with the baseline measurement obtained prior to initiation of the commercial trial period, for subjects randomized to each study SCS therapy. Numerical Rating Scale (NRS) was collected for overall pain experienced over
Interventions
- DEVICE Therapy A spinal cord stimulation parameter set using BIO-RNA system and associated components
- DEVICE Therapy B spinal cord stimulation parameter set using BIO-RNA system and associated components
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 136 participants |
| Start Date | 2018-08-01 |
| Est. Completion | 2020-03-27 |
| Phase | NA |
What the finished NCT03594266 record still lists
NCT03594266 is an interventional study that assigns participants to a tested intervention. The registered 136 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 (90% lower).
The record links to 0 conditions, and to 2 interventions - of which Therapy A spinal cord stimulation parameter set using BIO-RNA system and associated components is the first listed.
NCT03594266 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03594266 about?
NCT03594266 is a clinical study titled "Comparison of the Effects of Two Spinal Cord Stimulation (SCS) Therapies on Subject Reported Pain (BENEFIT-02)". A BIOTRONIK wearable stimulator will be utilized in order to investigate the effects of two study spinal cord stimulation (SCS) therapies on subject reported pain and paresthesia perception observed over 12 days of study stimulation testing following the conclusion of a successful SCS commercial tri...
What is the current status of trial NCT03594266?
This trial is currently completed. It is a NA study. The enrollment target is 136 participants. The study started on 2018-08-01. Estimated completion is 2020-03-27.
What interventions are being tested in trial NCT03594266?
The interventions under investigation include: Therapy A spinal cord stimulation parameter set using BIO-RNA system and associated components (DEVICE), Therapy B spinal cord stimulation parameter set using BIO-RNA system and associated components (DEVICE).
Who is sponsoring clinical trial NCT03594266?
This trial is sponsored by Biotronik, which has 30 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03594266's enrollment target sits among peer trials
136 722nd of 2000 higher than 1,275 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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