NCT02800863

TARGET Post-Approval Study

TARGET: A Post-Approval Study to Evaluate Targeted SCS Spinal Cord Stimulation (SCS) Dorsal Root Ganglion (DRG) Stimulation for the Management of Moderate to Severe Chronic, Intractable, Pain of the Lower Limbs Due to CRPS Types I and II

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 426 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 22 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A maximum of 426 adult subjects with moderate to severe chronic, intractable, pain of the lower limbs due to CRPS types I and II will undergo a trial of the Axium or Proclaim Neurostimulator System across up to 45 study sites in the United States. Only subjects who report a 50% or greater reduction in overall pain intensity through direct patient-reported percentage of pain relief will receive the permanent implant. Subjects will then return to the office for follow-up at 1, 3, 6 and 12 months post-permanent implant.

Conditions

• Complex Regional Pain Syndrome (CRPS)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-08-23
• Primary completion: 2021-09-23
• Completion: 2021-09-23
• First posted: 2016-06-15
• Last updated: 2024-07-08
• Results posted: 2024-07-08

Locations

44 sites across 1 country: United States