Projects

Research subject
Development and industrialization of intravenous vagal nerve stimulation catheter
Institution
Kyushu University Hospital
Principal investigator
Keita Saku
Contact (email)
saku.keita@ncvc.go.jp
Study outline
This study is aim to develop and industrialize the intravenous vagal nerve stimulation (iVNS) catheter system, which exerts rapid and stable bradycardia and multiple cardio-protective effects. We have developed an intravenous electrical catheter to stimulate the right vagal nerve as a clinical applicable minimally invasive technique. In the previous phase, we could produce the prototype of iVNS with control algorhythm which administrates the optimal electrical stimulation to the nerve. We formulated the regulatory strategy for obtaining the approval as “a device for inducing bradycardia”. We are now planning the First in Human clinical trial of iVNS.
  • Area of the study
    Other than cancer
    Development items
    Medical devices
    Regulatory approval
    Unapproved
    Main country where studies are conducted
    Led by Japan
    Number of participating countries, Number of participating institutions
    Number of participating countries:1, Number of participating institutions:未定
    Participating countries' names
    USA
    Study design
    Interventional study
    Development phase
    Phase II
    Sample size
    40
  • Website
    Not registered
    Intellectual property
    Yes
    Preclinical study
    Not completed yet
    Sponsoring company
    Yes
    Planning of licensing-out
    Planned
    Domestic funding
    Yes
    Funding abroad
    None in any countries
    Contract
    Not completed yet in any countries
    Procurement of investigational product
    Not completed yet in any countries
  • Steering Committee
    No
    Development roadmap
    Not fixed yet
    Stage of the study
    In preparation for protocol
    Protocol
    Permitting the use of a separate protocol in each country
    IRB application
    Not completed yet in any countries
    Data management
    In each country
    Monitoring
    On-site monitoring
    Consultation with regulatory authorities
    Completed in some of the countries
Current issues & challenges
(request for support, etc.)
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