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Clinical Trial Summary

The Conscious Sedation Single Arm Sub-Study is designed to evaluate the safety and performance of the CLAAS device implantation procedure using conscious sedation.


Clinical Trial Description

The Sub-Study is a prospective single arm trial evaluating a conscious sedation protocol. The Sub-Study will evaluate the safety and performance of the CLAAS device using conscious sedation in comparison with the device delivery safety and performance observed in the CLAAS arm of the RCT. The Sub-Study will be performed in accordance with all protocol requirements and all subjects will be evaluated for Primary Endpoint based on the product performance at the 45 days post procedure assessment. Enrollment in the Sub-Study will not commence until enrollment in the randomized cohort is complete, initial safety of the CLAAS system is confirmed by the DSMB and FDA approval of the Sub-Study has been granted through an IDE Supplement. All subjects enrolled in the conscious sedation single arm study will follow the same clinical protocol requirements and follow-up as the randomized subjects. The Sub-Study will be identified by an NCT that is separate from the RCT with Roll-in. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06049615
Study type Interventional
Source Conformal Medical, Inc
Contact
Status Not yet recruiting
Phase N/A
Start date April 1, 2024
Completion date January 1, 2026

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