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

Stopped early

Conditions studied: Chronic Pain

In brief

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.

Key facts

Study ID

NCT02373540

Run by

Nuvectra

People needed

91

Starts

2015-06-01

Expected to finish

2019-11-01

Last updated by the study team

2020-08-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Summit Healthcare Pain Clinic Associates — Show Low, Arizona, United States
• Coastal Pain and Spinal Diagnostics — Carlsbad, California, United States
• Samaritan Center for Medical Research — Los Gatos, California, United States
• Restore Orthopedics and Spine Center — Orange, California, United States
• Vitamed Research — Rancho Mirage, California, United States
• Spine & Nerve Diagnostic Center — Roseville, California, United States
• Relieve Pain Center — San Diego, California, United States
• Nona Medical Arts — Orlando, Florida, United States
• South Florida Clinical Research — South Miami, Florida, United States
• Ephraim McDowell Regional Medical Center — Danville, Kentucky, United States
• Brigham and Women's Hospital — Chestnut Hill, Massachusetts, United States
• Nevada Advanced Pain Specialists — Reno, Nevada, United States
• Garden State Pain Control — Clifton, New Jersey, United States
• OMNI Pain and Precision Medicine — Utica, New York, United States
• St. Luke's University Health Network — Bethlehem, Pennsylvania, United States
• Pennsylvania Pain and Spine — Chalfont, Pennsylvania, United States
• Universitatksklinikum Dusseldorf — Düsseldorf, Germany
• NCN-Neurochirurgische Praxis Neuss — Neuss, Germany

Full record on ClinicalTrials.gov

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