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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 : May 17, 2017
Sponsor:
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 : 200 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
Study Start Date : June 2015
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain




Primary Outcome Measures :
  1. Percent reduction in targeted pain at the 6 month post-implant follow up visit [ Time Frame: 6 months post-implant ]

Secondary Outcome Measures :
  1. Percent change in pain intensity through 24 months post-implantation [ Time Frame: through 2 years post implant ]
  2. Change in Oswestry Disability Index (ODI) [ Time Frame: through 2 years post implant ]
  3. Change in EQ-5D score through 24 months post-implantation [ Time Frame: through 2 years post implant ]
  4. Rate of device/procedure related events through 24 months post-implantation [ Time Frame: through 2 years post implant ]
  5. Rate of surgical intervention through 24 months post-implantation [ Time Frame: through 2 years post implant ]


Information from the National Library of Medicine

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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 and will be implanted with a permanent Algovita SCS system
  • Patient is willing and able to sign an IRB/EC approved informed consent

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: Sarah Mische, PhD Algovita.Post-Market@nuvectramed.com

Locations
Germany
Universitatksklinikum Dusseldorf Recruiting
Dusseldorf, Germany
Contact: Nuvectra       SMische@Nuvectramed.com   
Sponsors and Collaborators
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: May 17, 2017
Last Verified: May 2017

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