Clinical trial NCT02373540: 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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Chronic Pain
Keywords: spinal cord stimulation
chronic pain
failed back surgery syndrome
Lead sponsor: Nuvectra
Sponsor class: INDUSTRY
Collaborators: name: Bright Research Partners
First posted: 2015-02-27
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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

Primary outcomes:
measure: Percent reduction in targeted pain compared to baseline
timeFrame: 6 Month Follow-up Visit
Secondary outcomes:
measure: Percent reduction in targeted pain compared to baseline
timeFrame: 1, 3, 12, 18, and 24 Month Follow-up Visits
measure: Percent change in targeted pain intensity compared to baseline
timeFrame: 1, 3, 6, 12, 18, and 24 Month Follow-up Visits
measure: Change in disability compared to baseline
timeFrame: 1, 3, 6, 12, 18, and 24 Month Follow-up Visits
measure: Change in quality of life compared to baseline
timeFrame: 1, 3, 6, 12, 18, and 24 Month Follow-up Visits
measure: Willingness to undergo procedure again
timeFrame: 1, 3, 6, 12, 18, and 24 Month Follow-up Visits
measure: Rate of device-related and/or procedure-related Adverse Events (AEs)
timeFrame: From Implant through 24 Month Follow-up Visit
measure: Rate of surgical intervention of the SCS system
timeFrame: From Implant through 24 Month Follow-up Visit
Other outcomes:
Locations:
city: Show Low
country: United States
facility: Summit Healthcare Pain Clinic Associates
state: Arizona
city: Carlsbad
country: United States
facility: Coastal Pain and Spinal Diagnostics
state: California
city: Los Gatos
country: United States
facility: Samaritan Center for Medical Research
state: California
city: Orange
country: United States
facility: Restore Orthopedics and Spine Center
state: California
city: Rancho Mirage
country: United States
facility: Vitamed Research
state: California
city: Roseville
country: United States
facility: Spine & Nerve Diagnostic Center
state: California
city: San Diego
country: United States
facility: Relieve Pain Center
state: California
city: Orlando
country: United States
facility: Nona Medical Arts
state: Florida
city: South Miami
country: United States
facility: South Florida Clinical Research
state: Florida
city: Danville
country: United States
facility: Ephraim McDowell Regional Medical Center
state: Kentucky
city: Chestnut Hill
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Reno
country: United States
facility: Nevada Advanced Pain Specialists
state: Nevada
city: Clifton
country: United States
facility: Garden State Pain Control
state: New Jersey
city: Utica
country: United States
facility: OMNI Pain and Precision Medicine
state: New York
city: Bethlehem
country: United States
facility: St. Luke's University Health Network
state: Pennsylvania
city: Chalfont
country: United States
facility: Pennsylvania Pain and Spine
state: Pennsylvania
city: Dusseldorf
country: Germany
facility: Universitatksklinikum Dusseldorf
city: Neuss
country: Germany
facility: NCN-Neurochirurgische Praxis Neuss
Study officials:
affiliation: Nuvectra
name: Ben Tranchina
role: STUDY_DIRECTOR
References: