Chronic PainNCT02373540
Algovita Post-Market Clinical Study: Spinal Cord Stimulation to Treat Chronic Pain
An observational study of Chronic Pain, run by Nuvectra at 18 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Algovita Spinal Cord Stimulation system
- Type of treatment
- Medical device
- How many people
- 91 participants
- Where
- 18 sitesin 2 countries
- Study dates
- Jun 2015to Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic, intractable pain of the trunk and/or limbs who are appropriate to receive SCS therapy and successfully complete a stimulation trial.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
18 sites in 2 countries.
18 sites in 2 countries
United States16 sites
St. Luke's University Health Network
Bethlehem, Pennsylvania, 18015
Coastal Pain and Spinal Diagnostics
Carlsbad, California, 92009
Pennsylvania Pain and Spine
Chalfont, Pennsylvania, 18914
Brigham and Women's Hospital
Chestnut Hill, Massachusetts, 02467
Garden State Pain Control
Clifton, New Jersey, 07013
Ephraim McDowell Regional Medical Center
Danville, Kentucky, 40422
Samaritan Center for Medical Research
Los Gatos, California, 95032
Restore Orthopedics and Spine Center
Orange, California, 92868
Nona Medical Arts
Orlando, Florida, 32827
Vitamed Research
Rancho Mirage, California, 92270
Nevada Advanced Pain Specialists
Reno, Nevada, 89511
Spine & Nerve Diagnostic Center
Roseville, California, 95661
Relieve Pain Center
San Diego, California, 92103
Summit Healthcare Pain Clinic Associates
Show Low, Arizona, 85901
South Florida Clinical Research
South Miami, Florida, 33143
OMNI Pain and Precision Medicine
Utica, New York, 13502
Germany2 sites
Universitatksklinikum Dusseldorf
Düsseldorf, 40225
NCN-Neurochirurgische Praxis Neuss
Neuss, 41460
About this study
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
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.
- Conditions
- Chronic Pain
- Being tested
- Algovita Spinal Cord Stimulation system
- Keywords
- spinal cord stimulation, chronic pain, failed back surgery syndrome
- Medical subject headings
- Chronic Pain, Failed Back Surgery Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Algovita Spinal Cord Stimulation systemDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 Month Follow-up Visit
Secondary outcomes (7)
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.
Measured: 1, 3, 12, 18, and 24 Month Follow-up Visits
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.
Measured: 1, 3, 6, 12, 18, and 24 Month Follow-up Visits
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.
Measured: 1, 3, 6, 12, 18, and 24 Month Follow-up Visits
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.
Measured: 1, 3, 6, 12, 18, and 24 Month Follow-up Visits
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.
Measured: 1, 3, 6, 12, 18, and 24 Month Follow-up Visits
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).
Measured: From Implant through 24 Month Follow-up Visit
Rate of surgical intervention of the SCS system
To record the rate of surgical intervention of the SCS system.
Measured: From Implant through 24 Month Follow-up Visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2015 (estimated)
- Study startJun 2015
- Primary completionNov 2019
- Study completionNov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nuvectra
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bright Research Partners
- Responsible party
- Sponsor
- Investigators
- Ben Tranchina, Study director, Nuvectra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02373540
- Sponsor's protocol ID
- CLPR 0236
- Status last verified
- Aug 2020
- First submitted
- 23 Feb 2015
- Last updated
- 21 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02373540
- Acronym / sponsor ID
- CLPR 0236
- Conditions
- Chronic Pain
- Keywords
- spinal cord stimulation, chronic pain, failed back surgery syndrome
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 91 participants (actual)
- Lead sponsor
- NuvectraIndustry (pharma, biotech, devices)
- Collaborators
- Bright Research Partners
- Study start
- Jun 2015 (actual)
- Primary completion
- Nov 2019 (actual)
- Study completion
- Nov 2019 (actual)
- First posted
- 27 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic, intractable pain of the trunk and/or limbs who are appropriate to receive SCS therapy and successfully complete a stimulation trial.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Algovita Spinal Cord Stimulation system | Device | – |
Primary outcome
Percent reduction in targeted pain compared to baseline
Time frame: 6 Month Follow-up Visit
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.
7 secondary outcomes
Percent reduction in targeted pain compared to baseline
Time frame: 1, 3, 12, 18, and 24 Month Follow-up Visits
Percent change in targeted pain intensity compared to baseline
Time frame: 1, 3, 6, 12, 18, and 24 Month Follow-up Visits
Change in disability compared to baseline
Time frame: 1, 3, 6, 12, 18, and 24 Month Follow-up Visits
Change in quality of life compared to baseline
Time frame: 1, 3, 6, 12, 18, and 24 Month Follow-up Visits
Willingness to undergo procedure again
Time frame: 1, 3, 6, 12, 18, and 24 Month Follow-up Visits
Rate of device-related and/or procedure-related Adverse Events (AEs)
Time frame: From Implant through 24 Month Follow-up Visit
Rate of surgical intervention of the SCS system
Time frame: From Implant through 24 Month Follow-up Visit
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ben Tranchina study director
Nuvectra
18 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, run by Nuvectra at 18 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent reduction in targeted pain compared to baseline (time frame: 6 Month Follow-up Visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2020.