Clinical Trial: Severe Label Expansion for EVO Products Trial

U.S., July 30 -- ClinicalTrials.gov registry received information related to the study (NCT07090395) titled 'Severe Label Expansion for EVO Products Trial' on June 23.

Brief Summary: Title: Severe Label Expansion for EVO Positioner (SLEEP) Study Description: Single-arm study to determine the safety and effectiveness of treating severe obstructive sleep apnea using the EVO Sleep and Snore Device (ProSomnus Sleep Technologies, Pleasanton, CA).

Objectives: To determine the safety and effectiveness of the EVO Sleep and Snore Device in individuals with severe obstructive sleep apnea.

Endpoints: The primary effectiveness endpoint is the Sher criteria defined as a reduction of Apnea-Hypopnea Index (AHI) of at least 50% from the baseline value a...