Status:
WITHDRAWN
New Stereotactic Frame System for Neurosurgery
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
NaviNetics Inc.
Conditions:
Parkinson Disease
Essential Tremor
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief Summary
This study is designed to demonstrate an in-house developed re-attachable stereotactic system that can markedly reduce the overall deep brain stimulation (DBS) procedure time to greatly facilitate sub...
Detailed Description
Aims: This study will evaluate a new stereotactic device (D1 stereotactic system) designed to address shortcomings of current stereotactic systems by using a novel surface-mounted stereotactic system...
Eligibility Criteria
Inclusion
- Must be adult subjects with medically intractable neurological disorder who have been approved for DBS surgery by the interdisciplinary Mayo DBS committee.
- Competent and willing to provide signed, informed consent to participate in the study.
- Competent and willing to provide written, informed consent to participate in the study.
Exclusion
- Pregnant subjects, prisoners, individuals ages less than 18 and any subjects identified as unsuitable for DBS surgery by the Mayo Clinic DBS committee.
- Subjects unable to communicate with the investigator and staff.
- Any health condition that in the investigator's opinion should preclude participation in this study.
Key Trial Info
Start Date :
January 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04283812
Start Date
January 1 2023
End Date
June 1 2023
Last Update
August 3 2022
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