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Clinical Trial Summary

The objective of this study was continued commercial evaluation of the intraoperative safety and performance of the H-TTS for the placement of ventilation tubes in pediatric patients undergoing a tympanostomy procedure under moderate sedation and local anesthetic.


Clinical Trial Description

The study was a multi-site, prospective and retrospective, treatment-only post-market study of the H-TTS. The study was performed in a commercial environment. Patients were already have a scheduled tympanostomy procedure with the H-TTS under moderate sedation and local anesthetic. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03503591
Study type Observational
Source Preceptis Medical, Inc.
Contact
Status Completed
Phase
Start date January 29, 2016
Completion date August 2021

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