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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05535556
• Other study ID #: 1-2021-0063
• Status: Recruiting
• Start date: July 14, 2022
• Est. completion date: February 14, 2024

Study information

• Verified date: September 2022
• Source: Yonsei University
• Contact: Jin Woo Chang
• Phone: 82-02-2228-2150
• Email: JCHANG[@]yuhs.ac
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 14, 2024
• Est. primary completion date: July 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dystonia
• Epilepsy
• Essential Tremor
• Parkinson Disease

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University Health System, Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complications occurred during surgery	Evaluate mechanical damage to the DBS machine immediately after surgery	Immediately after surgery
Secondary	Surgical time	Check the time required for surgery	Intraoperative
Secondary	The occurrence of wound-related complications	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	The 1 day after surgery, 3 weeks after surgery, 6 months after surgery