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Safety and Efficacy of Vagus Nerve Stimulator in Patients With Rheumatoid Arthritis (RA)

NCT03437473 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2018-12-27

No results posted yet for this study

Summary

Multi-site, first-in-human study to assess safety and efficacy of an active implantable Vagus Nerve Stimulation (VNS) device in 15 adult patients with active moderate-to-severe rheumatoid arthritis who have had an incomplete response or intolerability to at least two different mechanisms of action.

Conditions

Interventions

DEVICE

SetPoint Medical Neurostimulation of the Cholinergic Anti-inflammatory Pathway System

Active Implantable Vagus Nerve Stimulation device.

Sponsors & Collaborators

  • SetPoint Medical Corporation

    lead INDUSTRY

Principal Investigators

  • Mark Genovese, MD · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-03-06
Primary Completion
2018-12-10
Completion
2018-12-10
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 NCT03437473 on ClinicalTrials.gov