CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 10 enrolled
Drug / intervention
GiMer Medical MN 1000 External Stimulatordevice
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/NCT03285113
NCT03285113N/ACompleted
CompareCT.gov

A Single-arm, Open Label, Single Center Pilot Study to Confirm the Safety of Dorsal Root Ganglia (DRG) and Ultrahigh Frequency Spinal Cord Stimulator in Patients With Chronic Lower Limb Pain

GiMer Medical·interventional·Posted Sep 15, 2017·Updated Jan 22, 2021

In Brief

A clinical study evaluating GiMer Medical MN 1000 External Stimulator for Failed Back Surgery Syndrome and Complex Regional Pain Syndrome (CRPS). Completed, enrolled 10 participants across 1 site.

Detailed Summary

This study is a prospective, single-arm, open label, single center pilot study to confirm the safety of a ultrahigh frequency DRG stimulator in patients with chronic lower limb pain. The actual trial length is 5 days. Pts will be given ultrahigh frequency pulse stimulation, and VAS will be obtained after 3-4 hours of each stimulation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFailed Back Surgery Syndrome, Complex Regional Pain Syndrome (CRPS)
CountriesTaiwan
CollaboratorsChina Medical University Hospital

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedSep 15, 2017
Enrollment StartMar 3, 2017
Primary CompletionFeb 5, 2018
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 8.8 years ago

Interventions

GiMer Medical MN 1000 External Stimulatordevice

Trial stimulator to generate pulsed ultrahigh frequency (\>200KHz) electrical stimulation, delivered via lead around DRG, in treating pain. Similar with current market available Spinal Cord Stimulators but with a higher stimulation frequency (hundred KHz) range.