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Trial record 8 of 373 for:    Recruiting, Not yet recruiting, Available Studies | "Chronic Pain"

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

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ClinicalTrials.gov Identifier: NCT02373540
Recruitment Status : Recruiting
First Posted : February 27, 2015
Last Update Posted : September 26, 2018
Sponsor:
Collaborator:
Bright Research Partners
Information provided by (Responsible Party):
Nuvectra

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 Type : Observational
Estimated Enrollment : 120 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
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain




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.



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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

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


Contacts
Contact: Robin Solinsky Algovita.post-market@nuvectramed.com

Locations
United States, California
Coastal Pain and Spinal Diagnostics Recruiting
Carlsbad, California, United States, 92009
Contact: Suzanne Nanson       suzanne@coastalpainresearch.com   
Principal Investigator: Yogesh Patel, MD         
Perlman Clinic Recruiting
La Jolla, California, United States, 92037
Contact: Chelsea Harkness       charkness@perlmanclinic.com   
Principal Investigator: Brandon Van Noord, MD         
Samaritan Center for Medical Research Recruiting
Los Gatos, California, United States, 95032
Contact: Van Lieou       vlieou@samaritan-research.com   
Principal Investigator: Maia Chakerian, MD         
Restore Orthopedics and Spine Center Recruiting
Orange, California, United States, 92868
Contact: Greys Belteton       gbelteton@restoreorthopedics.com   
Principal Investigator: Eric Chang, MD         
Vitamed Research Recruiting
Rancho Mirage, California, United States, 92270
Contact: Chloe Grout       chloe@vitamedresearch.com   
Principal Investigator: Tobias Moeller-Bertram, MD         
Orthopedic Pain Specialists Withdrawn
Santa Monica, California, United States, 90404
United States, Florida
Nona Medical Arts Recruiting
Orlando, Florida, United States, 32827
Contact: Elena Taneva-Cholakova       etaneva@nonamedicalarts.com   
Principal Investigator: Richard Gayles, MD         
South Florida Clinical Research Recruiting
South Miami, Florida, United States, 33143
Contact: Damian Sosa       dsosa@sflcresearch.com   
Principal Investigator: Julian Naranjo, MD         
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Chestnut Hill, Massachusetts, United States, 02467
Contact: Ashish Bhandari       ABHANDARI@BWH.HARVARD.EDU   
Principal Investigator: Robert Yong, MD         
United States, Nevada
Nevada Advanced Pain Specialists Recruiting
Reno, Nevada, United States, 89511
Contact: Lorelei Gettman       lorelei@nvadvancedpain.com   
Principal Investigator: Ali Nairizi, MD         
United States, New Jersey
Garden State Pain Control Recruiting
Clifton, New Jersey, United States, 07013
Contact: Jordan Weeks       jordanwgardenstatepaincontrol@gmail.com   
Principal Investigator: Saurabh Dang, MD         
University Pain Medical Center Withdrawn
Somerset, New Jersey, United States, 08873
United States, New York
OMNI Pain and Precision Medicine Recruiting
Utica, New York, United States, 13502
Contact: Mary S Sullivan       Mary.Sullivan@killpain.com   
Principal Investigator: Nameer Haider, MD         
United States, Pennsylvania
St. Luke's University Health Network Recruiting
Bethlehem, Pennsylvania, United States, 18015
Contact: Susan Hahn       susan.hahn2@sluhn.org   
Principal Investigator: Steven Falowski, MD         
Germany
Universitatksklinikum Dusseldorf Completed
Dusseldorf, Germany, 40225
NCN-Neurochirurgische Praxis Neuss Recruiting
Neuss, Germany, 41460
Contact: Sabina Piechotta       praxis.wille@gmail.com   
Principal Investigator: Christian Wille, Prof med         
Sponsors and Collaborators
Nuvectra
Bright Research Partners
Investigators
Study Director: Bernie Bosley Nuvectra

Responsible Party: Nuvectra
ClinicalTrials.gov Identifier: NCT02373540     History of Changes
Other Study ID Numbers: CLPR 0236
First Posted: February 27, 2015    Key Record Dates
Last Update Posted: September 26, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
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:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms