Algovita Spinal Cord Stimulation System Hi-Fi Study

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-02

Study Completion Date

2020-04-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of Clinical Outcomes of Pulse Widths in Spinal Cord Stimulation

NCT03756012

Back Pain Pain

COMPLETED NA

SCS as an Option for Chronic Low Back and/or Leg Pain Instead of Surgery

NCT04676022

Chronic Pain

COMPLETED NA

Evaluation of Conventional and Long Pulse Widths During a Temporary Spinal Cord Stimulation Trial

NCT03526055

Spinal Cord Stimulation Pain, Back Pain

COMPLETED NA

Safety and Effectiveness of Spinal Cord Stimulation With Automatic Control to Treat Chronic Pain in an Extended Trial

NCT02161627

Chronic Pain

COMPLETED NA

Analgesic Efficacy of High Frequency Spinal Cord Stimulation

NCT01400282

Lowback and Leg Pain

UNKNOWN PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ultra-high pulse width

Ultra-high pulse width stimulation using the Algovita System

Group Type ACTIVE_COMPARATOR

Ultra-high pulse width stimulation

Intervention Type DEVICE

Algovita Spinal Cord Stimulation System with associated components

Traditional pulse width

Traditional pulse width stimulation using the Algovita System

Group Type ACTIVE_COMPARATOR

Traditional pulse width stimulation

Intervention Type DEVICE

Algovita Spinal Cord Stimulation System with associated components

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ultra-high pulse width stimulation

Algovita Spinal Cord Stimulation System with associated components

Intervention Type DEVICE

Traditional pulse width stimulation

Algovita Spinal Cord Stimulation System with associated components

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No