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Comparison of the Electric Plasma Surgical Tool "PlasmaBlade" for Replacement of the Deep Brain Stimulation (DBS) Devices With Conventional Surgery

Sponsor
Yonsei University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05535556
Collaborator
(none)
50
Enrollment
1
Location
19.1
Anticipated Duration (Months)
2.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The deep brain stimulation is surgical technique used for the Parkinson's disease, essential tremor, dystonia, epilepsy, and psychiatric diseases. A pulse generator or battery (implanted pulse generator, IPG) is a need for replacement every few years. In general, electric cautery(BOVIE), which is commonly used in surgery, cannot be used when the deep brain stimulation machine is inserted, so conventional tools such as scissors and knives are used for replacement surgery. However, in the process, damage to the machine may be inflicted by knives, scissors, etc., and in the worst case, the machine may be unusable, resulting in financial and human consumption.

Plasma Blade is currently used for tissue incision and coagulation in Korea, and is the only insurance-recognized tool in Korea for the replacement surgery of a cardiovascular implantable electronic device (CIED). The deep brain stimulation machine has a structure very similar to that of the heart electronics. In addition, the plasma blade was used to replace the deep brain stimulation machine overseas.The safety is reported in the surgery, so the plasma blade deep brain stimulation machine has been replaced in Korea. The investigators would like to check the safety and effectiveness for use in surgery.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Comparison of the Electric Plasma Surgical Tool "PlasmaBlade" for Replacement of the Deep Brain Stimulation (DBS) Devices With Conventional Surgery
    Actual Study Start Date :
    Jul 14, 2022
    Anticipated Primary Completion Date :
    Jul 14, 2023
    Anticipated Study Completion Date :
    Feb 14, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Complications occurred during surgery [Immediately after surgery]

      Evaluate mechanical damage to the DBS machine immediately after surgery

    Secondary Outcome Measures

    1. Surgical time [Intraoperative]

      Check the time required for surgery

    2. The occurrence of wound-related complications [The 1 day after surgery, 3 weeks after surgery, 6 months after surgery]

      the occurrence of short-term/long-term complications (hematoma, infection, wound spread, and changes in mechanical resistance values) the 1 day after surgery, 3 weeks after surgery, and 6 months after surgery

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Men and women over the age of 19

    • Those who voluntarily agree to participate in this clinical trial and are willing to comply with the clinical trial protocol

    • Persons who have previously undergone deep brain stimulation for Parkinson's disease, essential tremor, dystonia, epilepsy, etc.

    • Those who need replacement of deep brain stimulation machine

    Exclusion Criteria:
    • Those who cannot be under general anesthesia

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Yonsei University Health System, Severance Hospital Seoul Korea, Republic of

    Sponsors and Collaborators

    • Yonsei University

    Investigators

    • Principal Investigator: Jin Woo Chang, Department of Neurosurgery, Brain Research Institute, Yonsei University College of Medicine, Seoul, South Korea

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yonsei University
    ClinicalTrials.gov Identifier:
    NCT05535556
    Other Study ID Numbers:
    • 1-2021-0063
    First Posted:
    Sep 10, 2022
    Last Update Posted:
    Sep 10, 2022
    Last Verified:
    Sep 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Parkinson Disease
    Dystonia
    Essential Tremor

    Study Results

    No Results Posted as of Sep 10, 2022