Algovita Spinal Cord Stimulation System Hi-Fi Study

March 9, 2021 updated by: Nuvectra

Clinical Trial Comparing Ultra-High Versus Traditional Pulse Widths Using the ALGOVITA® SCS System High Fidelity Stimulation in the Treatment of Persistent or Recurrent Back and/or Leg Pain Following Spinal Surgery

The objective of this study is to obtain post-market clinical outcome data for the Algovita SCS System when used on-label, according to the applicable directions for use, using high fidelity tonic stimulation at either ultra-high pulse width or traditional pulse width for the treatment of persistent or recurrent back and/or leg pain following spinal surgery.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

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 (Actual)

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.
20

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 Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85712
        • Pain Institute of Southern Arizona
    • California
      • Newport Beach, California, United States, 92660
        • Newport Beach Headache & Pain
      • Santa Rosa, California, United States, 95401
        • Summit Pain Alliance
    • Colorado
      • Colorado Springs, Colorado, United States, 80919
        • Spinal Diagnostics & Pain Management
    • Kansas
      • Overland Park, Kansas, United States, 66210
        • Mid-America PolyClinic & Interventional Pain Management Specialists
    • Louisiana
      • Shreveport, Louisiana, United States, 71105
        • WK River Cities Clinical Research Center
    • Massachusetts
      • Chestnut Hill, Massachusetts, United States, 02467
        • Brigham & Women's Hospital
    • Ohio
      • Chillicothe, Ohio, United States, 45601
        • Adena Spine Center
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Comprehensive Spine Center at Rhode Island Hospital

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with FBSS defined as persistent or recurrent back and/or leg pain despite one or more anatomically successful back surgeries for the same original pain.
  • Age 18-75 years old at consent.
  • Targeted pain intensity of ≥ 5 out of 10 on the Baseline visit NRS.
  • ODI score of 41-80 out of 100 at the Baseline visit.
  • Appropriate candidate for the surgical procedure and Algovita SCS therapy based on the clinical judgment of the investigator and the Algovita Instructions for Provider (IFP) in the Nuvectra product manuals.
  • On stable pain medications for at least 28 days prior to consent. Stable is defined as no new or discontinued pain medications and no changes to total daily dose of any pain medications.
  • Willing and capable of providing informed consent.
  • Willing and able of complying with the study-related requirements, procedures, and visits.
  • Speaks English as a primary language (as the Algovita patient manuals are only currently available in English).
  • Has adequate cognitive ability to use the subject devices (e.g., PPC, PoP), as determined by the investigator.

Exclusion Criteria:

  • Has a medical/psychological/psychiatric condition/disorder that could interfere with study procedures as determined by the investigator.
  • Has a coexisting pain condition that might confound pain ratings, as determined by the investigator.
  • Has a condition currently requiring or likely to require the use of MRI or diathermy.
  • Has an existing drug pump, SCS System, or other active implantable device.
  • Has any prior SCS experience.
  • Pregnant or planning to become (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile, or be at least 2 years postmenopausal).
  • For subjects with diabetes, HbA1c ≥ 8.5% as measured at the Baseline visit (or within the 3 months prior to the Baseline visit).
  • Participating in another clinical trial that could affect the outcomes or requirements of this study as determined by the investigator.
  • Involved in an injury claim under current litigation or have a pending or approved workers compensation claim.

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: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

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.
Active Comparator: Ultra-high pulse width
Ultra-high pulse width stimulation using the Algovita System
Device: Ultra-high pulse width stimulation
Algovita Spinal Cord Stimulation System with associated components
Active Comparator: Traditional pulse width
Traditional pulse width stimulation using the Algovita System
Device: Traditional pulse width stimulation
Algovita Spinal Cord Stimulation System with associated components

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
Effectiveness of targeted pain reduction compared to baseline in each treatment arm
Time Frame: Week 25

The percentage of participants who experience at least a 50 percent reduction in targeted pain from baseline, as assessed by Numeric Rating Scale (NRS). The Numeric Rating Scale (NRS) will range from 0 to 10 with a higher score indicating a higher level of pain.

Effectiveness will be compared both descriptively and statistically between the two randomized treatment groups using crossover analysis methods.
Week 25
Rate of serious study-related adverse events (AEs) in each treatment arm
Time Frame: From Permanent Implant through Week 25
The rate of serious study-related AEs. Study-related AEs are defined as any device, procedure and therapy/stimulation-related AEs.
From Permanent Implant through Week 25

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Effectiveness of targeted pain reduction compared to baseline in each treatment arm
Time Frame: Week 12 and Months 12, 18 and 24
The percentage of participants who experience at least a 50 percent reduction in targeted pain as assessed by Numeric Rating Scale (NRS). The Numeric Rating Scale (NRS) will range from 0 to 10 with a higher score indicating a higher level of pain.
Week 12 and Months 12, 18 and 24
Effectiveness of back and/or leg pain reduction compared to baseline in each treatment arm
Time Frame: Weeks 12 and 25, and Months 12, 18 and 24
The percentage of participants who experience at least a 50 percent reduction in back and/or leg pain as assessed by Numeric Rating Scale (NRS). The Numeric Rating Scale (NRS) will range from 0 to 10 with a higher score indicating a higher level of pain.
Weeks 12 and 25, and Months 12, 18 and 24
Effectiveness of targeted, back and/or leg pain reduction compared to baseline in each treatment arm
Time Frame: Weeks 12 and 25, and Months 12, 18 and 24
The percentage of participants who experience at least a 50 percent reduction in targeted, back and/or leg pain as assessed by a Visual Analog Scale (VAS). The Visual Analog Scale (VAS) will range from 0 mm (no pain) to 100 mm (worst pain imaginable). A higher score indicates a higher level of pain.
Weeks 12 and 25, and Months 12, 18 and 24
Change in targeted, back and/or leg pain compared to baseline in each treatment arm
Time Frame: Weeks 12 and 25, and Months 12, 18 and 24
The mean change and percent change from baseline in targeted, back and/or leg pain as assessed by a Numeric Rating Scale (NRS). The Numeric Rating Scale (NRS) will range from 0 to 10 with a higher score indicating a higher level of pain.
Weeks 12 and 25, and Months 12, 18 and 24
Change in targeted, back and/or leg pain compared to baseline in each treatment arm
Time Frame: Weeks 12 and 25, and Months 12, 18 and 24
The mean change and percent change from baseline in targeted, back and/or leg pain as assessed by a Visual Analog Scale (VAS). The Visual Analog Scale (VAS) will range from 0 mm (no pain) to 100 mm (worst pain imaginable). A higher score indicates a higher level of pain.
Weeks 12 and 25, and Months 12, 18 and 24
Clinician Global Impression of Change score in each treatment arm
Time Frame: Weeks 12 and 25, and Months 12, 18 and 24
The Investigator's assessment of change in the overall status of the participant using the standard Clinician Global Impression of Change ranging from 1 (very much improved) to 7 (very much worse).
Weeks 12 and 25, and Months 12, 18 and 24
Change in disability compared to baseline in each treatment arm
Time Frame: Weeks 12 and 25, and Months 12, 18 and 24
The change from baseline in disability as measured by the Oswestry Disability Index. The Oswestry Disability Index is scored between 0 and 100 with higher scores indicating a greater disability.
Weeks 12 and 25, and Months 12, 18 and 24
Change in quality of life compared to baseline in each treatment arm
Time Frame: Weeks 12 and 25, and Months 12, 18 and 24
The change from baseline in quality of life as measured by the EQ-5D-5L, a standardized measure of health status.
Weeks 12 and 25, and Months 12, 18 and 24
Change in patient activity per the Pain Disability Index score in each treatment arm
Time Frame: Weeks 12 and 25, and Months 12, 18 and 24
The change from baseline in patient activity as measured by the Pain Disability Index score. The Pain Disability Index is a self-report asking participants to rate how much pain interferes in seven areas of life activity using a 0 (no disability) to 10 (total disability) numeric rating scale.
Weeks 12 and 25, and Months 12, 18 and 24
Patient Global Impression of Change score in each treatment arm
Time Frame: Weeks 12 and 25, and Months 12, 18 and 24
The participant's assessment of change in their overall status using the standard Patient Global Impression of Change ranging from 1 (very much improved) to 7 (very much worse).
Weeks 12 and 25, and Months 12, 18 and 24
Participant satisfaction per the subject satisfaction survey outcome in each treatment arm
Time Frame: Weeks 12 and 25, and Months 12, 18 and 24
Participant satisfaction using a subject satisfaction survey (5 point Likert scale format) ranging from very satisfied to very dissatisfied.
Weeks 12 and 25, and Months 12, 18 and 24
Evaluation of trial success rates
Time Frame: From Trial Implant to End of Trail
The percentage of participants that have a successful trial phase, defined as at least a 50 percent reduction in targeted pain compared to baseline.
From Trial Implant to End of Trail
Rate of surgical re-intervention of the SCS system
Time Frame: From Permanent Implant through Month 24
Rate of surgical re-intervention of the SCS system for participants with a permanent implant.
From Permanent Implant through Month 24

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.
Nuvectra

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.
Bright Research Partners

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 Director: Ben Tranchina, Nuvectra

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.
November 2, 2018

Primary Completion (Actual)

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.
April 27, 2020

Study Completion (Actual)

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.
April 27, 2020

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).
July 26, 2018

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.
August 7, 2018

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.
August 9, 2018

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.
March 11, 2021

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.
March 9, 2021

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.
March 1, 2021

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.
  • CLRE 1092

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

Yes

product manufactured in and exported from the U.S.

Yes

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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