MedTrace Logo

Long Term Extension Study For SPM-005 Participants

NCT01552538 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2016-11-01

No results posted yet for this study

Summary

This will be an open label multicenter study of the safety and efficacy of an active implantable vagal nerve stimulation (VNS) device in patients with rheumatoid arthritis. Patients who complete study SPM-005 will be enrolled in this study at the time of the last visit of the preceding study.

Conditions

Interventions

DEVICE

Cyberonics VNS System

Stimulation with an active implantable electrical vagal nerve stimulation device

Sponsors & Collaborators

  • SetPoint Medical Corporation

    lead INDUSTRY

Principal Investigators

  • Ralph Zitnik, M.D. · SetPoint Medical

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2018-05-31
Completion
2018-10-31

Countries

  • Bosnia and Herzegovina
  • Croatia
  • Netherlands

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 NCT01552538 on ClinicalTrials.gov