Algovita Post-Market Clinical Study: Spinal Cord Stimulation to Treat Chronic Pain
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
1 other identifier
observational
91
2 countries
18
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2015
Longer than P75 for all trials
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 23, 2015
CompletedFirst Posted
Study publicly available on registry
February 27, 2015
CompletedStudy Start
First participant enrolled
June 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2019
CompletedAugust 21, 2020
August 1, 2020
4.4 years
February 23, 2015
August 20, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent reduction in targeted pain compared to baseline
Percentage of participants who experience at least a 50 percent reduction in targeted pain from baseline, as assessed by Numeric Rating Scale (NRS). The Numeric Rating Scale (NRS) will range from 0 to 10 with a higher score indicating a higher level of pain.
6 Month Follow-up Visit
Secondary Outcomes (7)
Percent reduction in targeted pain compared to baseline
1, 3, 12, 18, and 24 Month Follow-up Visits
Percent change in targeted pain intensity compared to baseline
1, 3, 6, 12, 18, and 24 Month Follow-up Visits
Change in disability compared to baseline
1, 3, 6, 12, 18, and 24 Month Follow-up Visits
Change in quality of life compared to baseline
1, 3, 6, 12, 18, and 24 Month Follow-up Visits
Willingness to undergo procedure again
1, 3, 6, 12, 18, and 24 Month Follow-up Visits
- +2 more secondary outcomes
Interventions
Eligibility Criteria
Patients with chronic, intractable pain of the trunk and/or limbs who are appropriate to receive SCS therapy and successfully complete a stimulation trial.
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nuvectralead
- Bright Research Partnerscollaborator
Study Sites (18)
Summit Healthcare Pain Clinic Associates
Show Low, Arizona, 85901, United States
Coastal Pain and Spinal Diagnostics
Carlsbad, California, 92009, United States
Samaritan Center for Medical Research
Los Gatos, California, 95032, United States
Restore Orthopedics and Spine Center
Orange, California, 92868, United States
Vitamed Research
Rancho Mirage, California, 92270, United States
Spine & Nerve Diagnostic Center
Roseville, California, 95661, United States
Relieve Pain Center
San Diego, California, 92103, United States
Nona Medical Arts
Orlando, Florida, 32827, United States
South Florida Clinical Research
South Miami, Florida, 33143, United States
Ephraim McDowell Regional Medical Center
Danville, Kentucky, 40422, United States
Brigham and Women's Hospital
Chestnut Hill, Massachusetts, 02467, United States
Nevada Advanced Pain Specialists
Reno, Nevada, 89511, United States
Garden State Pain Control
Clifton, New Jersey, 07013, United States
OMNI Pain and Precision Medicine
Utica, New York, 13502, United States
St. Luke's University Health Network
Bethlehem, Pennsylvania, 18015, United States
Pennsylvania Pain and Spine
Chalfont, Pennsylvania, 18914, United States
Universitatksklinikum Dusseldorf
Düsseldorf, 40225, Germany
NCN-Neurochirurgische Praxis Neuss
Neuss, 41460, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ben Tranchina
Nuvectra
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2015
First Posted
February 27, 2015
Study Start
June 1, 2015
Primary Completion
November 1, 2019
Study Completion
November 1, 2019
Last Updated
August 21, 2020
Record last verified: 2020-08