Parkinson DiseaseNCT05535556
Comparison of the Electric Plasma Surgical Tool "PlasmaBlade" for Replacement of the Deep Brain Stimulation (DBS) Devices With Conventional Surgery
An observational study of Parkinson Disease and Essential Tremor, run by Yonsei University at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Parkinson Disease, Essential Tremor, Dystonia
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Jul 2022to 14 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: For those who need to replace the deep brain stimulation machine, and those who have given voluntary consent
Who may be able to join
- 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
Who cannot join
- Those who cannot be under general anesthesia
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei University Health System, Severance Hospital
Seoul
Jin Woo Chang, 82-02-2228-2150, JCHANG@yuhs.ac
About this study
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.
- Conditions
- Parkinson Disease, Essential Tremor, Dystonia, Epilepsy
- Medical subject headings
- Parkinson Disease, Essential Tremor, Dystonia, Epilepsy
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications occurred during surgery
Evaluate mechanical damage to the DBS machine immediately after surgery
Measured: Immediately after surgery
Secondary outcomes (2)
Surgical time
Check the time required for surgery
Measured: Intraoperative
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
Measured: The 1 day after surgery, 3 weeks after surgery, 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2022
- Study start14 Jul 2022
- Primary completion14 Jul 2023 (estimated)
- Study completion14 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jin Woo Chang, Principal investigator, Department of Neurosurgery, Brain Research Institute, Yonsei University College of Medicine, Seoul, South Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05535556
- Sponsor's protocol ID
- 1-2021-0063
- Status last verified
- Sep 2022
- First submitted
- 7 Sep 2022
- Last updated
- 10 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Electric Plasma Surgical Tool "PlasmaBlade" for Replacement of the Deep Brain Stimulation (DBS) Devices With Conventional Surgery
- ClinicalTrials.gov ID
- NCT05535556
- Acronym / sponsor ID
- 1-2021-0063
- Conditions
- Parkinson Disease, Essential Tremor, Dystonia, Epilepsy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 14 Jul 2022 (actual)
- Primary completion
- 14 Jul 2023 (estimated)
- Study completion
- 14 Feb 2024 (estimated)
- First posted
- 10 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- For those who need to replace the deep brain stimulation machine, and those who have given voluntary consent
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Those who cannot be under general anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Complications occurred during surgery
Time frame: Immediately after surgery
Evaluate mechanical damage to the DBS machine immediately after surgery
2 secondary outcomes
Surgical time
Time frame: Intraoperative
The occurrence of wound-related complications
Time frame: The 1 day after surgery, 3 weeks after surgery, 6 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jin Woo Chang principal investigator
Department of Neurosurgery, Brain Research Institute, Yonsei University College of Medicine, Seoul, South Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and Essential Tremor, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jin Woo Chang (82-02-2228-2150, JCHANG@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complications occurred during surgery (time frame: Immediately after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2022.