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

Recruiting

• Conditions: Essential Tremor; Epilepsy; Parkinson Disease; Dystonia

• Registration Number: NCT05535556
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-14
• Status Verified: 2022-09
• Study First Submitted: 2022-09-07
• Study First Submitted QC: 2022-09-09
• Last Update Submitted: 2022-09-09
• Study First Posted: 2022-09-10
• Last Update Posted: 2022-09-10
• Primary Completion: 2023-07-14
• Study Completion: 2024-02-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complications occurred during surgery	Immediately after surgery	Evaluate mechanical damage to the DBS machine immediately after surgery

Secondary Outcome Measures

Name	Time	Method
Surgical time	Intraoperative	Check the time required for surgery
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

Trial Locations

Locations (1)

Yonsei University Health System, Severance Hospital; 🇰🇷 Seoul, Korea, Republic of