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Long Term Observational Study of a Vagal Nerve Stimulation Device in Crohn's Disease

NCT02951650 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2017-08-03

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 VNS device in patients with Crohn's Disease.

Conditions

  • Crohn Disease

Interventions

DEVICE

Cyberonics VNS

Vagus nerve stimulation

Sponsors & Collaborators

  • SetPoint Medical Corporation

    lead INDUSTRY

Principal Investigators

  • Geert D'Haens, M.D., Ph.D. · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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
2015-01-31
Primary Completion
2018-05-31
Completion
2018-08-31

Countries

  • Croatia
  • Italy
  • Netherlands
  • Sweden

Study Locations

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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 NCT02951650 on ClinicalTrials.gov