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

NCT ID: NCT02373540

Last Updated: 2020-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

91 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-30

Study Completion Date

2019-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Algovita Spinal Cord Stimulation system

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bright Research Partners

INDUSTRY

Sponsor Role collaborator

Nuvectra

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ben Tranchina

Role: STUDY_DIRECTOR

Nuvectra

Locations

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Summit Healthcare Pain Clinic Associates

Show Low, Arizona, United States

Site Status

Coastal Pain and Spinal Diagnostics

Carlsbad, California, United States

Site Status

Samaritan Center for Medical Research

Los Gatos, California, United States

Site Status

Restore Orthopedics and Spine Center

Orange, California, United States

Site Status

Vitamed Research

Rancho Mirage, California, United States

Site Status

Spine & Nerve Diagnostic Center

Roseville, California, United States

Site Status

Relieve Pain Center

San Diego, California, United States

Site Status

Nona Medical Arts

Orlando, Florida, United States

Site Status

South Florida Clinical Research

South Miami, Florida, United States

Site Status

Ephraim McDowell Regional Medical Center

Danville, Kentucky, United States

Site Status

Brigham and Women's Hospital

Chestnut Hill, Massachusetts, United States

Site Status

Nevada Advanced Pain Specialists

Reno, Nevada, United States

Site Status

Garden State Pain Control

Clifton, New Jersey, United States

Site Status

OMNI Pain and Precision Medicine

Utica, New York, United States

Site Status

St. Luke's University Health Network

Bethlehem, Pennsylvania, United States

Site Status

Pennsylvania Pain and Spine

Chalfont, Pennsylvania, United States

Site Status

Universitatksklinikum Dusseldorf

Düsseldorf, , Germany

Site Status

NCN-Neurochirurgische Praxis Neuss

Neuss, , Germany

Site Status

Countries

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United States Germany

Other Identifiers

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CLPR 0236

Identifier Type: -

Identifier Source: org_study_id

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