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

November 5, 2024 updated by: Biotronik, Inc.

BENEFIT-03 Clinical Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • New South Wales
      • Broadmeadow, New South Wales, Australia, 2292
        • Genesis Research Services
      • Hurstville, New South Wales, Australia, 2220
        • Australian Medical Research
      • Wahroonga, New South Wales, Australia, 2076
        • Sydney Pain Research Centre
    • Queensland
      • Noosa Heads, Queensland, Australia, 4567
        • Sunshine Coast Clinical Research
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Monash Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Currently indicated for SCS therapy for the treatment of low back and/or leg pain
  • Planned permanent implant of BIOTRONIK's Prospera SCS System with HomeStream Remote Management
  • Planned placement of two BIOTRONIK Resilience SCS trial leads
  • Documented scores of ≥ 60 mm out of 100 mm on the Visual Analog Scale (VAS) for both overall pain intensity and pain intensity in the index area of pain, assessed at the time of enrollment
  • Willing and able to comply with all study requirements, including all required procedures, phone and/or video calls, and study visits
  • Age greater than or equal to 18 years and less than 80 years
  • Able to understand the nature of the study and provide written informed consent
  • Able to read, understand, and speak English
  • Patient's pain-related medication regimen is stable 4 weeks prior to the baseline evaluation
  • Oswestry Disability Index (ODI) score of 41 to 80 out of 100
  • Passed psychological evaluation
  • For diabetic patients: minimum of one HbA1c test within the last 6 months, with most recent result ≤ 8.0%

Exclusion Criteria:

  • Any contraindication for SCS therapy
  • Patients with an implanted pacemaker, defibrillator, or any other medical contraindication for SCS therapy
  • Currently implanted with an infusion pump or any implantable neurostimulator device
  • Previously implanted with a neurostimulation system or prior participation in a trial period for a neurostimulation system
  • Currently enrolled in any investigational device or drug trial for the management of chronic pain
  • Patients who have undergone spinal surgery within 12 months prior to enrollment
  • Patients currently involved in an active WorkCover insurance claim and/or active litigation related to injury associated with indication for SCS
  • Patients with a documented history of substance abuse (narcotics, alcohol, etc.) or substance dependency (other than prescribed) in the 6 months prior to enrollment
  • Patients currently displaying opioid-seeking behavior
  • Presence of any life-threatening, underlying illness
  • Life expectancy less than 1 year
  • Patients reporting pregnancy at the time of enrollment or intending to become pregnant during the 2-year study duration
  • Patients with opioid dosages > 120 morphine milligram equivalents (MME) per day
  • Patients with poor compliance for pain management regimen
  • Patients with a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the investigator
  • Patients with pain originating from peripheral vascular disease
  • Current diagnosis of a coagulation disorder or bleeding diathesis
  • Patients with a diagnosis of severe thoracic scoliosis that is likely to preclude SCS lead placement
  • Patients who are immunocompromised and/or at high risk for infection
  • Patients with a documented history of allergic response or sensitivity to material(s) required for the study (e.g. adhesives, titanium, silicone, etc.)

At the conclusion of the trial period, the absence of the following exclusion criteria should be confirmed before proceeding with the permanent Prospera SCS System implant:

  • Reduction in overall pain of less than 50% from baseline, assessed using VAS
  • Unsuccessful trial period as otherwise determined by the investigator
  • Determined by the investigator to be a poor candidate for permanent Prospera SCS System implant per standard of care (e.g. due to infection, non-compliance with pain medication regimen, paresis, clumsiness, numbness, and other)

Additionally, pre-operative screening for staphylococcus aureus (MRSA/MSSA) must be conducted after the SCS trial period and prior to implantation of the permanent device.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: BIOTRONIK Prosper SCS (Spinal Cord Stimulation) System
Eligible participants will be permanently implanted with a BIOTRONIK Prospera SCS (Spinal Cord Stimulation) System with HomeStream Remote Management.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall Responder Rate to the BIOTRONIK Prospera SCS System Therapy
Time Frame: 6 months post-implant
The purpose of primary endpoint 1 is to evaluate the overall responder rate of participants to the BIOTRONIK SCS Therapy at the 6-month follow-up interval. To be classified as a responder, a participant must achieve a reduction in overall pain intensity of at least a 50% from baseline, assessed using the Visual Analog Scale (VAS).
6 months post-implant
Primary Safety Information on the BIOTRONIK Prospera SCS System
Time Frame: 6 months post-implant
The purpose of primary endpoint 2 is to collect primary safety information on the BIOTRONIK Prospera SCS System from permanent implant through the 6-month follow-up interval.
6 months post-implant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biotronik, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Biotronik Australia Pty Ltd.
BIOTRONIK Neuro

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Paul Verrills, MD, Metro Pain Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 20, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 21, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 24, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 6, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BENEFIT-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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