CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 58 enrolled
Drug / intervention
Intellis neurostimulator 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/NCT04466111
NCT04466111N/ACompleted
CompareCT.gov

A Post-Market, Observational Clinical Study to Evaluate the Effects of Differential Target Multiplexed DTM™ SCS Programming in Treating Intractable Chronic Upper Extremity Limb Pain

SGX Procura LLC·observational·Posted Jul 10, 2020·Updated Aug 19, 2024

In Brief

An observational study evaluating Intellis neurostimulator system for Upper Limb and Pain. Completed, enrolled 58 participants across 1 site.

Detailed Summary

This is a post-market, open-label, prospective, multi-center, observational study evaluating upper limb pain relief with the DTM™ SCS programming approach. Data at follow-up visits will be compared to baseline assessments collected at the beginning of the study.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsUpper Limb, Pain
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedJul 10, 2020
Enrollment StartSep 8, 2020
Primary CompletionJul 29, 2022
Study CompletionMar 9, 2023
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 6.0 years ago

Interventions

Intellis neurostimulator systemdevice

The study will use the commercially available IntellisTM neurostimulator and compatible SCS system components from Medtronic using stimulation parameters within the specifications approved for use in the approved indications. The study will stimulate the cervical dorsal columns of the spinal cord.