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TARGET Post-Approval Study

NCT02800863 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 426

Last updated 2024-07-08

Study results available
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Summary

The purpose of this prospective, multicenter, single arm post-approval study is to demonstrate continued safety of the Axium and Proclaim Neurostimulator System for dorsal root ganglion (DRG) stimulation. The primary endpoint is the 12-month serious adverse event rate for permanent implants.

Conditions

  • Complex Regional Pain Syndrome (CRPS)

Interventions

DEVICE

Dorsal Root Ganglion (DRG) Stimulation (Axium™ Neurostimulator System)

Electrical stimulation of the DRG using the Axium™ Neurostimulator System

DEVICE

Dorsal Root Ganglion (DRG) Stimulation (Proclaim™ Neurostimulator System)

Electrical Stimulation of the DRG using the Proclaim™ Neurostimulator System.

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Ann Jannu, PhD, CCRP · Abbott Neuromodulation

Eligibility

Min Age
22 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-23
Primary Completion
2021-09-23
Completion
2021-09-23

Countries

  • United States

Study Locations

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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 NCT02800863 on ClinicalTrials.gov