Algovita Post-Market Clinical Study: Spinal Cord Stimulation to Treat Chronic Pain
Status: | Recruiting |
---|---|
Conditions: | Chronic Pain, Chronic Pain |
Therapuetic Areas: | Musculoskeletal |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/4/2019 |
Start Date: | June 2015 |
End Date: | June 2021 |
Contact: | Hannah Bearinger |
Email: | Algovita.post-market@nuvectramed.com |
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
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.
Spinal Cord Stimulation system when used, on-label, according to the applicable directions
for use.
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
We found this trial at
19
sites
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Bethlehem, Pennsylvania
Principal Investigator: Steven Falowski, MD
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Chestnut Hill, Massachusetts 02467
Principal Investigator: Robert Yong, MD
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2035 W Taylor St
Chicago, Illinois
Chicago, Illinois
(312) 996-4350
Principal Investigator: Konstantin Slavin, MD
University of Illinois at Chicago A major research university in the heart of one of...
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Los Gatos, California 95032
Principal Investigator: Maia Chakerian, MD
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Orange, California 92868
Principal Investigator: Eric Chang, MD
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5578 Longley Lane
Reno, Nevada 89511
Reno, Nevada 89511
Principal Investigator: Ali Nairizi, MD
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1528 Eureka Road
Roseville, California 95661
Roseville, California 95661
Principal Investigator: Brian Joves, MD
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Show Low, Arizona 85901
Principal Investigator: Dax Trujillo, MD
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South Miami, Florida 33143
Principal Investigator: Julian Naranjo, MD
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