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Prospective Evaluation of a Palato-Pharyngeal Implant System (PPIS) Obstructive Sleep Apnea Syndrome (OSAS)

Obstructive Sleep Apnea Clinical Trial

Official title:
Prospective Evaluation of a Palato-Pharyngeal Implant System (PPIS) for the Treatment of Snoring and Obstructive Sleep Apnea Syndrome (OSAS): a Pilot Study

Clinical Trial Summary

Prospective Evaluation of a Palato-Pharyngeal Implant System (PPIS) for the Treatment of Snoring and Obstructive Sleep Apnea Syndrome (OSAS): A Pilot Study.

Clinical Trial Description

The clinical study is designed as single center, prospective, non-randomized and non-blinded clinical study. Since the surgical procedure is independent of the population a single center study is applied. A double-blind study is not possible considering the implantation procedure with the surgeon always knowing if the device is set. Therefore, the study is designed to be non-randomized and non-blinded as a pilot trial. To reduce bias and other influences of single surgeon skills a principal investigator and one investigator are part of the clinical study. Further, subjects with previous treatments such as Pillar implant or previous airway surgery other than nasal, adenoid, tonsil or UPPP are excluded from the clinical study. A double-blind study is not possible considering the implantation procedure with the surgeon always knowing if the device is set. Therefore, the study is designed to be non-randomized and non-blinded as a pilot trial. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03640793
Study type Interventional
Source Medartis AG
Contact
Status Completed
Phase N/A
Start date October 9, 2017
Completion date March 4, 2024
View Details
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