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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02373540
Recruitment Status : Terminated
First Posted : February 27, 2015
Last Update Posted : August 21, 2020
Sponsor:
Collaborator:
Bright Research Partners
Information provided by (Responsible Party):
Nuvectra

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Chronic Pain Device: Algovita Spinal Cord Stimulation system

Study Design
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Study Type : Observational
Actual Enrollment : 91 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Actual Study Start Date : June 2015
Actual Primary Completion Date : November 2019
Actual Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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).

  7. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02373540


Locations
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Sponsors and Collaborators
Nuvectra
Bright Research Partners
Investigators
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Study Director: Ben Tranchina Nuvectra
More Information
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Responsible Party: Nuvectra
ClinicalTrials.gov Identifier: NCT02373540    
Other Study ID Numbers: CLPR 0236
First Posted: February 27, 2015    Key Record Dates
Last Update Posted: August 21, 2020
Last Verified: August 2020

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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
Keywords provided by Nuvectra:
spinal cord stimulation
chronic pain
failed back surgery syndrome
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations