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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02373540
• Other study ID #: CLPR 0236
• Status: Terminated
• Start date: June 2015
• Est. completion date: November 2019

Study information

• Verified date: August 2020
• Source: Nuvectra
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 91
• Est. completion date: November 2019
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Device:
• Algovita Spinal Cord Stimulation system

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Nuvectra	Bright Research Partners

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	1, 3, 12, 18, and 24 Month Follow-up Visits
Secondary	Percent change in targeted pain intensity compared to baseline	Percent reduction or actual reduction from baseline in targeted pain intensity, 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.	1, 3, 6, 12, 18, and 24 Month Follow-up Visits
Secondary	Change in disability compared to baseline	Change from baseline in disability as measured by Oswestry Disability Index (ODI). The Oswestry Disability Index is scored between 0 and 100 with higher scores indicating a greater disability.	1, 3, 6, 12, 18, and 24 Month Follow-up Visits
Secondary	Change in quality of life compared to baseline	Change from baseline in quality of life as measured by EQ-5D, a standardized measure of health status.	1, 3, 6, 12, 18, and 24 Month Follow-up Visits
Secondary	Willingness to undergo procedure again	To record the participants willingness to undergo the procedure again using a question (yes/no) if the participant would be willing to undergo the procedure again.	1, 3, 6, 12, 18, and 24 Month Follow-up Visits
Secondary	Rate of device-related and/or procedure-related Adverse Events (AEs)	To record the rate of device-related and/or procedure-related Adverse Events (AEs).	From Implant through 24 Month Follow-up Visit
Secondary	Rate of surgical intervention of the SCS system	To record the rate of surgical intervention of the SCS system.	From Implant through 24 Month Follow-up Visit