CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 10 enrolled
Drug / intervention
StimRouter Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00665132
NCT00665132Phase 2Completed
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Acute Human Study: StimRouter for Peripheral Nerve Stimulation of Discrete Peripheral Nerves

Bioness Inc·interventional·Posted Apr 23, 2008·Updated Jun 6, 2016

In Brief

A Phase 2 clinical trial evaluating StimRouter System for Unilateral Carpal Tunnel Syndrome. Completed, enrolled 10 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUnilateral Carpal Tunnel Syndrome
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 23, 2008
Enrollment StartApr 1, 2008
Primary CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 18.2 years ago

Interventions

StimRouter Systemdevice

Implanted with StimRouter System receive 6 hours (or less if not tolerated by the Subject)of electrical therapeutic stimulation each day for a total of 5 days (from start of successful programming)