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

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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.


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
Santa Monica, California 90403
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Bethlehem, Pennsylvania
Principal Investigator: Steven Falowski, MD
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Bethlehem, PA
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Carlsbad, California
Principal Investigator: Yogesh Patel, MD
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Carlsbad, CA
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Chalfont, Pennsylvania 18914
Principal Investigator: David Qu, MD
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Chalfont, PA
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Chestnut Hill, Massachusetts 02467
Principal Investigator: Robert Yong, MD
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Chestnut Hill, MA
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2035 W Taylor St
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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Chicago, IL
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Clifton, New Jersey 07013
Principal Investigator: Saurabh Dang, MD
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Clifton, NJ
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Dusseldorf,
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La Jolla, California 92037
Principal Investigator: Brandon Van Noord, MD
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La Jolla, CA
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Los Gatos, California 95032
Principal Investigator: Maia Chakerian, MD
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Los Gatos, CA
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Orange, California 92868
Principal Investigator: Eric Chang, MD
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Orange, CA
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Orlando, Florida 32827
Principal Investigator: Richard Gayles, MD
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Orlando, FL
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Rancho Mirage, California 92270
Principal Investigator: Tobias Moeller-Bertram, MD
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Rancho Mirage, CA
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5578 Longley Lane
Reno, Nevada 89511
Principal Investigator: Ali Nairizi, MD
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from
Reno, NV
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1528 Eureka Road
Roseville, California 95661
Principal Investigator: Brian Joves, MD
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Roseville, CA
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Show Low, Arizona 85901
Principal Investigator: Dax Trujillo, MD
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Show Low, AZ
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Somerset, New Jersey 08873
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Somerset, NJ
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South Miami, Florida 33143
Principal Investigator: Julian Naranjo, MD
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South Miami, FL
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Utica, New York 13502
Principal Investigator: Nameer Haider, MD
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Utica, NY
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