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

NCT04683718 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-11-06

No results posted yet for this study

Summary

The BENEFIT-03 Clinical Study is a first in human, prospective, multi-center, single-arm, interventional feasibility study to be conducted in Australia. The purpose of the BENEFIT-03 study is to collect initial safety and effectiveness data on the BIOTRONIK Prosper SCS (Spinal Cord Stimulation) System with HomeStream Remote Management. Enrolled participants will complete a SCS trial period per the standard of care utilizing the BIOTRONIK Resilience percutaneous SCS trial leads and the BIOTRONIK Prospera External Pulse Generator (EPG). Following a successful trial period, participants will be implanted with a permanent BIOTRONIK Prospera Implantable Pulse Generator (IPG). Implanted participants will be followed for 24 months post-implant with in-office visits and remote management visits.

Conditions

  • Chronic Low-back Pain
  • Chronic 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.

Sponsors & Collaborators

  • Biotronik Australia Pty Ltd.

    collaborator INDUSTRY

  • BIOTRONIK Neuro

    collaborator UNKNOWN

  • Biotronik, Inc.

    lead INDUSTRY

Principal Investigators

  • Paul Verrills, MD · Metro Pain Group

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-20
Primary Completion
2026-01-31
Completion
2027-01-31

Countries

  • Australia

Study Locations

More Related Trials

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 NCT04683718 on ClinicalTrials.gov