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Observational, Post Market Study in Treating Chronic Upper Extremity Limb Pain

NCT04466111 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 58

Last updated 2024-08-19

Study results available
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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.

Conditions

Interventions

DEVICE

Intellis neurostimulator system

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.

Sponsors & Collaborators

  • SGX Procura LLC

    lead INDUSTRY

Principal Investigators

  • Ricardo Vallejo, MD · SGX Medical

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-08
Primary Completion
2022-07-29
Completion
2023-03-09
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04466111 on ClinicalTrials.gov