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

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: Terminated
• Conditions: Chronic Pain
• Intervention / Treatment: Device: Algovita Spinal Cord Stimulation system

• Study Type: Observational
• Enrollment (Actual): 91

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent reduction in targeted pain compared to baseline	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

Outcome Measure	Measure Description	Time Frame
Percent reduction in targeted pain compared to baseline	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	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	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	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	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)	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	To record the rate of surgical intervention of the SCS system.	From Implant through 24 Month Follow-up Visit

Collaborators and Investigators

• Sponsor: Nuvectra
• Collaborators: Bright Research Partners
• Investigators: Study Director: Ben Tranchina, Nuvectra

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Actual): November 1, 2019
• Study Completion (Actual): November 1, 2019

Study Registration Dates

• First Submitted: February 23, 2015
• First Submitted That Met QC Criteria: February 26, 2015
• First Posted (Estimate): February 27, 2015

Study Record Updates

• Last Update Posted (Actual): August 21, 2020
• Last Update Submitted That Met QC Criteria: August 20, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: chronic pain; spinal cord stimulation; failed back surgery syndrome
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID 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