Algovita Spinal Cord Stimulation System Hi-Fi Study

NCT03622866 | Terminated FDA Device

• 1 other identifier: CLRE 1092
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 10

Brief Summary

The objective of this study is to obtain post-market clinical outcome data for the Algovita SCS System when used on-label, according to the applicable directions for use, using high fidelity tonic stimulation at either ultra-high pulse width or traditional pulse width for the treatment of persistent or recurrent back and/or leg pain following spinal surgery.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (2)

• Effectiveness of targeted pain reduction compared to baseline in each treatment arm

  The 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. Effectiveness will be compared both descriptively and statistically between the two randomized treatment groups using crossover analysis methods.

  Week 25

• Rate of serious study-related adverse events (AEs) in each treatment arm

  The rate of serious study-related AEs. Study-related AEs are defined as any device, procedure and therapy/stimulation-related AEs.

  From Permanent Implant through Week 25

Secondary Outcomes (13)

• Effectiveness of targeted pain reduction compared to baseline in each treatment arm

  Week 12 and Months 12, 18 and 24

• Effectiveness of back and/or leg pain reduction compared to baseline in each treatment arm

  Weeks 12 and 25, and Months 12, 18 and 24

• Effectiveness of targeted, back and/or leg pain reduction compared to baseline in each treatment arm

  Weeks 12 and 25, and Months 12, 18 and 24

• Change in targeted, back and/or leg pain compared to baseline in each treatment arm

  Weeks 12 and 25, and Months 12, 18 and 24

• Change in targeted, back and/or leg pain compared to baseline in each treatment arm

  Weeks 12 and 25, and Months 12, 18 and 24

Study Arms (2)

Ultra-high pulse width

ACTIVE COMPARATOR

Ultra-high pulse width stimulation using the Algovita System

Device: Ultra-high pulse width stimulation

Traditional pulse width

ACTIVE COMPARATOR

Traditional pulse width stimulation using the Algovita System

Device: Traditional pulse width stimulation

Interventions

Ultra-high pulse width stimulation DEVICE

Algovita Spinal Cord Stimulation System with associated components

Ultra-high pulse width

Traditional pulse width stimulation DEVICE

Algovita Spinal Cord Stimulation System with associated components

Traditional pulse width

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with FBSS defined as persistent or recurrent back and/or leg pain despite one or more anatomically successful back surgeries for the same original pain.
• Age 18-75 years old at consent.
• Targeted pain intensity of ≥ 5 out of 10 on the Baseline visit NRS.
• ODI score of 41-80 out of 100 at the Baseline visit.
• Appropriate candidate for the surgical procedure and Algovita SCS therapy based on the clinical judgment of the investigator and the Algovita Instructions for Provider (IFP) in the Nuvectra product manuals.
• On stable pain medications for at least 28 days prior to consent. Stable is defined as no new or discontinued pain medications and no changes to total daily dose of any pain medications.
• Willing and capable of providing informed consent.
• Willing and able of complying with the study-related requirements, procedures, and visits.
• Speaks English as a primary language (as the Algovita patient manuals are only currently available in English).
• Has adequate cognitive ability to use the subject devices (e.g., PPC, PoP), as determined by the investigator.

You may not qualify if:

• Has a medical/psychological/psychiatric condition/disorder that could interfere with study procedures as determined by the investigator.
• Has a coexisting pain condition that might confound pain ratings, as determined by the investigator.
• Has a condition currently requiring or likely to require the use of MRI or diathermy.
• Has an existing drug pump, SCS System, or other active implantable device.
• Has any prior SCS experience.
• Pregnant or planning to become (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile, or be at least 2 years postmenopausal).
• For subjects with diabetes, HbA1c ≥ 8.5% as measured at the Baseline visit (or within the 3 months prior to the Baseline visit).
• Participating in another clinical trial that could affect the outcomes or requirements of this study as determined by the investigator.
• Involved in an injury claim under current litigation or have a pending or approved workers compensation claim.

Sponsors & Collaborators

• Nuvectra: lead
• Bright Research Partners: collaborator

Study Sites (10)

Pain Institute of Southern Arizona

Tucson, Arizona, 85712, United States

Location

Newport Beach Headache & Pain

Newport Beach, California, 92660, United States

Location

Summit Pain Alliance

Santa Rosa, California, 95401, United States

Location

Spinal Diagnostics & Pain Management

Colorado Springs, Colorado, 80919, United States

Location

Mid-America PolyClinic & Interventional Pain Management Specialists

Overland Park, Kansas, 66210, United States

Location

WK River Cities Clinical Research Center

Shreveport, Louisiana, 71105, United States

Location

Brigham & Women's Hospital

Chestnut Hill, Massachusetts, 02467, United States

Location

Adena Spine Center

Chillicothe, Ohio, 45601, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Comprehensive Spine Center at Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ben Tranchina

  Nuvectra

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Subjects who receive a permanent implant will be randomly assigned in a 1:1 ratio to one of the two sequences of treatment. Randomization schedules for each site will be prepared by the contract research organization (CRO) statistician and uploaded into a role-limited module of the study database. In order to avoid any potential bias, each site will designate an unblinded coordinator (UC). The UC, Nuvectra field personnel (FP) and the CRO will be unblinded to the treatment group. The participant and other site staff will be blinded to the treatment group.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: During the Treatment Phase of the study, all subjects will receive both treatments under a crossover design. Subjects will undergo 12 weeks of treatment in each group with a 1-week washout between groups.

Study Record Dates

• First Submitted: July 26, 2018
• First Posted: August 9, 2018
• Study Start: November 2, 2018
• Primary Completion: April 27, 2020
• Study Completion: April 27, 2020
• Last Updated: March 11, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)