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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

Tracking Information
First Submitted Date February 23, 2015
First Posted Date February 27, 2015
Last Update Posted Date August 21, 2020
Actual Study Start Date June 2015
Actual Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 24, 2018)
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.
Original Primary Outcome Measures
 (submitted: February 26, 2015)
Percent reduction in targeted pain at the 6 month post-implant follow up visit [ Time Frame: 6 months post-implant ]
Change History
Current Secondary Outcome Measures
 (submitted: September 24, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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).
  • 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.
Original Secondary Outcome Measures
 (submitted: February 26, 2015)
  • Percent change in pain intensity through 24 months post-implantation [ Time Frame: through 2 years post implant ]
  • Change in Oswestry Disability Index (ODI) [ Time Frame: through 2 years post implant ]
  • Change in EQ-5D score through 24 months post-implantation [ Time Frame: through 2 years post implant ]
  • Rate of device/procedure related events through 24 months post-implantation [ Time Frame: through 2 years post implant ]
  • Rate of surgical intervention through 24 months post-implantation [ Time Frame: through 2 years post implant ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Algovita Post-Market Clinical Study: Spinal Cord Stimulation to Treat Chronic Pain
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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Chronic Pain
Intervention Device: Algovita Spinal Cord Stimulation system
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: August 20, 2020)
91
Original Estimated Enrollment
 (submitted: February 26, 2015)
200
Actual Study Completion Date November 2019
Actual Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02373540
Other Study ID Numbers CLPR 0236
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement Not Provided
Current Responsible Party Nuvectra
Original Responsible Party Same as current
Current Study Sponsor Nuvectra
Original Study Sponsor Same as current
Collaborators Bright Research Partners
Investigators
Study Director: Ben Tranchina Nuvectra
PRS Account Nuvectra
Verification Date August 2020