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NCT00665132 · ClinicalTrials.gov registry record · Phase 1
Acute Human Study: StimRouter for Peripheral Nerve Stimulation of Discrete Peripheral Nerves
A Phase 1 study, sponsored by Bioness.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT00665132: Completed Phase 1 study, sponsored by Bioness.
NCT00665132 is a Phase 1 study that has completed, run by Bioness. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00665132, a Phase 1 study, has completed, sponsored by Bioness.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
This study is being done to see how well a new investigational medical device, the StimRouter (STR) System, will work to treat the chronic pain in people who have failed previous treatments for Carpal Tunnel Syndrome (CTS) pain, including surgery. These people have been treated for CTS pain before including surgical carpal tunnel release, but without good results, and they are still having pain. The study will look at both the good and bad effects of the StimRouter System for treating this kind of pain and as a general peripheral nerve stimulation device for treating chronic pain. The study will also help to understand other possible uses for the StimRouter System.
Primary Outcome
Success of device implantation was defined as uncomplicated minimally-invasive implantation of the StimRouter Lead near the targeted peripheral median nerve, resulting in production of desired paresthesias in the sensory distribution of the median nerve when active peripheral nerve stimulation was applied. This outcome parameter was intended to serve as an indication that the lead and electrode stimulating positions could be correctly placed while still maintaining the minimal invasiveness of th
Interventions
- DEVICE StimRouter System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2008-04 |
| Est. Completion | 2008-12 |
| Phase | Phase 1 |
What the finished NCT00665132 record still lists
NCT00665132 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 1 intervention - of which StimRouter System is the first listed.
NCT00665132 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00665132 about?
NCT00665132 is a clinical study titled "Acute Human Study: StimRouter for Peripheral Nerve Stimulation of Discrete Peripheral Nerves". This study is being done to see how well a new investigational medical device, the StimRouter (STR) System, will work to treat the chronic pain in people who have failed previous treatments for Carpal Tunnel Syndrome (CTS) pain, including surgery. These people have been treated for CTS pain before i...
What is the current status of trial NCT00665132?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2008-04. Estimated completion is 2008-12.
What interventions are being tested in trial NCT00665132?
The interventions under investigation include: StimRouter System (DEVICE).
Who is sponsoring clinical trial NCT00665132?
This trial is sponsored by Bioness, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00665132's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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