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

Nuvectra

Status: Terminated

Conditions: Chronic Pain

Treatments: Device: Algovita Spinal Cord Stimulation system

Study type: Observational

Funder types: Industry

Identifiers

NCT02373540

CLPR 0236

Details and patient eligibility

About

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.

Enrollment: 91 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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