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Pilot Study to Examine the Feasibility of the Dynamic Interferential Spinal Cord Stimulation System™ (DISCSS™)

NCT03341000 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2024-04-08

Study results available
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Summary

This study evaluates use of DISCSS vis SCS. Thirty (30) patients with back pain greater than leg pain who were candidates for Spinal Cord Stimulation (SCS) and have successfully completed a percutaneous trial with a commercially available SCS system will be trialed with a 3-4 day exposure to the investigational DISCSS™ device. The trial will be conducted at 3-5 U.S. centers. The percutaneous trial leads from the commercial system will be connected to the External Pulse Generator of the DISCSS™ Trial System and the patients will be trialed for an additional three-four days.

Conditions

Interventions

DEVICE

DISCSS Device

This pilot feasibility study will explore and help determine optimal settings and configuration of the DISCSS™ System with patients that have completed a percutaneous trial with a commercially available SCS trial system within the first 3-5 days of the current study.

Sponsors & Collaborators

  • Meagan Medical

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-01
Primary Completion
2020-02-03
Completion
2020-02-03
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 NCT03341000 on ClinicalTrials.gov