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Clinical Trial Summary

The purpose of the study is to determine if using SIS System for DBS planning results in less distance between the planned target location and the actual implanted lead location than DBS planning without SIS System.


Clinical Trial Description

This is a prospective, controlled, open-label, multicenter post-market trial to compare standard of care DBS surgery to standard of care plus visualization with the SIS System. The purpose of the study is to determine if using SIS System for DBS planning results in less distance between the planned target location and the actual implanted lead location than DBS planning without SIS System. Parkinson's Disease subjects indicated for DBS will undergo standard DBS surgery with preoperative planning for targeting of STN or GPi as indicated. Subjects will be followed through six months after initial DBS programming to collect clinical outcomes. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05774041
Study type Observational
Source Surgical Information Sciences Inc.
Contact Lisa Ingham
Phone 612-242-2226
Email lisa.ingham@surgicalis.com
Status Recruiting
Phase
Start date October 19, 2023
Completion date December 2024

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