NCT04683718View on ClinicalTrials.gov

A First in Human Feasibility Study to Evaluate the Safety and Effectiveness of the BIOTRONIK Prospera SCS System with HomeStream Remote Management

NAActive, not recruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

September 20, 2021

Primary Completion Date

January 31, 2026

Study Completion Date

January 31, 2027

Conditions
Chronic Low-back PainChronic Leg Pain
Interventions
DEVICE

Permanent implant of a BIOTRONIK Prospera SCS (Spinal Cord Stimulation) System with HomeStream Remote Management

The Prospera SCS System is a rechargeable, 16-electrode, MRI conditional Spinal Cord Stimulation system that delivers electrical stimulation to the dorsal column of the spinal cord for the treatment of chronic intractable pain of the trunk and/or limbs.

Trial Locations (5)

2076

Sydney Pain Research Centre, Wahroonga

2220

Australian Medical Research, Hurstville

2292

Genesis Research Services, Broadmeadow

3168

Monash Clinical Research, Clayton

4567

Sunshine Coast Clinical Research, Noosa

Sponsors

Lead Sponsor

Biotronik, Inc.
All Listed Sponsors
collaborator

Biotronik Australia Pty Ltd.

INDUSTRY

collaborator

BIOTRONIK Neuro

UNKNOWN

lead

Biotronik, Inc.

INDUSTRY