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

• ClinicalTrials.gov Identifier: NCT02373540
• Recruitment Status: Terminated
• First Posted: February 27, 2015
• Last Update Posted: August 21, 2020
• Sponsor: Nuvectra
• 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 ]

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

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

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