Algovita Post-Market Clinical Study: Spinal Cord Stimulation to Treat Chronic Pain

August 20, 2020 updated by: Nuvectra

Real-world Evaluation of Outcome Data Under a Prospective, Observational, Post-Market Clinical Study, Using the Algovita SCS System to Treat Patients With Chronic Pain of the Trunk and/or Limbs Per the Applicable Indications for Use

The purpose of this study is to obtain real-world clinical outcome data for the Algovita Spinal Cord Stimulation system when used, on-label, according to the applicable directions for use.

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.
Observational

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.
91

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

  • Germany
      • Dusseldorf, Germany, 40225
        • Universitatksklinikum Dusseldorf
      • Neuss, Germany, 41460
        • NCN-Neurochirurgische Praxis Neuss
  • United States
    • Arizona
      • Show Low, Arizona, United States, 85901
        • Summit Healthcare Pain Clinic Associates
    • California
      • Carlsbad, California, United States, 92009
        • Coastal Pain and Spinal Diagnostics
      • Los Gatos, California, United States, 95032
        • Samaritan Center for Medical Research
      • Orange, California, United States, 92868
        • Restore Orthopedics and Spine Center
      • Rancho Mirage, California, United States, 92270
        • Vitamed Research
      • Roseville, California, United States, 95661
        • Spine & Nerve Diagnostic Center
      • San Diego, California, United States, 92103
        • Relieve Pain Center
    • Florida
      • Orlando, Florida, United States, 32827
        • Nona Medical Arts
      • South Miami, Florida, United States, 33143
        • South Florida Clinical Research
    • Kentucky
      • Danville, Kentucky, United States, 40422
        • Ephraim McDowell Regional Medical Center
    • Massachusetts
      • Chestnut Hill, Massachusetts, United States, 02467
        • Brigham and Women's Hospital
    • Nevada
      • Reno, Nevada, United States, 89511
        • Nevada Advanced Pain Specialists
    • New Jersey
      • Clifton, New Jersey, United States, 07013
        • Garden State Pain Control
    • New York
      • Utica, New York, United States, 13502
        • OMNI Pain and Precision Medicine
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • St. Luke's University Health Network
      • Chalfont, Pennsylvania, United States, 18914
        • Pennsylvania Pain and Spine

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with chronic, intractable pain of the trunk and/or limbs who are appropriate to receive SCS therapy and successfully complete a stimulation trial.

Description

Inclusion Criteria:

  • Patient is eligible for SCS therapy according to the Algovita SCS system Indications for Use statement
  • Patient had successful Algovita SCS system stimulation trial with an Algovita SCS system and will be implanted with a permanent Algovita SCS system; prior approval must be obtained from the Sponsor if another SCS system was used for the stimulation trial
  • Patient is willing and able to sign an IRB/EC approved informed consent, and in the United States, a Privacy Protection Authorization, as required

Exclusion Criteria:

  • Patient is contraindicated for an Algovita SCS system
  • Patient has a cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain relief or complete study assessments
  • Patient has a life expectancy of less than 2 years
  • Patient is participating in another clinical study that would confound data analysis
  • Patient has a coexisting pain condition that might confound pain ratings

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

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
Percent reduction in targeted pain compared to baseline
Time Frame: 6 Month Follow-up Visit
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.
6 Month Follow-up Visit

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
Percent reduction in targeted pain compared to baseline
Time Frame: 1, 3, 12, 18, and 24 Month Follow-up Visits
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.
1, 3, 12, 18, and 24 Month Follow-up Visits
Percent change in targeted pain intensity compared to baseline
Time Frame: 1, 3, 6, 12, 18, and 24 Month Follow-up Visits
Percent reduction or actual reduction from baseline in targeted pain intensity, 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.
1, 3, 6, 12, 18, and 24 Month Follow-up Visits
Change in disability compared to baseline
Time Frame: 1, 3, 6, 12, 18, and 24 Month Follow-up Visits
Change from baseline in disability as measured by Oswestry Disability Index (ODI). The Oswestry Disability Index is scored between 0 and 100 with higher scores indicating a greater disability.
1, 3, 6, 12, 18, and 24 Month Follow-up Visits
Change in quality of life compared to baseline
Time Frame: 1, 3, 6, 12, 18, and 24 Month Follow-up Visits
Change from baseline in quality of life as measured by EQ-5D, a standardized measure of health status.
1, 3, 6, 12, 18, and 24 Month Follow-up Visits
Willingness to undergo procedure again
Time Frame: 1, 3, 6, 12, 18, and 24 Month Follow-up Visits
To record the participants willingness to undergo the procedure again using a question (yes/no) if the participant would be willing to undergo the procedure again.
1, 3, 6, 12, 18, and 24 Month Follow-up Visits
Rate of device-related and/or procedure-related Adverse Events (AEs)
Time Frame: From Implant through 24 Month Follow-up Visit
To record the rate of device-related and/or procedure-related Adverse Events (AEs).
From Implant through 24 Month Follow-up Visit
Rate of surgical intervention of the SCS system
Time Frame: From Implant through 24 Month Follow-up Visit
To record the rate of surgical intervention of the SCS system.
From Implant through 24 Month Follow-up Visit

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.
June 1, 2015

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.
November 1, 2019

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.
November 1, 2019

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).
February 23, 2015

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.
February 26, 2015

First Posted (Estimate)

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.
February 27, 2015

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.
August 21, 2020

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.
August 20, 2020

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.
August 1, 2020

More Information

Terms related to this study

Keywords

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.
  • CLPR 0236

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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