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Algovita Spinal Cord Stimulation System Hi-Fi Study

NCT03622866 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-03-11

No results posted yet for this study

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

Interventions

DEVICE

Ultra-high pulse width stimulation

Algovita Spinal Cord Stimulation System with associated components

DEVICE

Traditional pulse width stimulation

Algovita Spinal Cord Stimulation System with associated components

Sponsors & Collaborators

  • Bright Research Partners

    collaborator INDUSTRY

  • Nuvectra

    lead INDUSTRY

Principal Investigators

  • Ben Tranchina · Nuvectra

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-02
Primary Completion
2020-04-27
Completion
2020-04-27
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03622866 on ClinicalTrials.gov