Inspire Medical ((INSP)) announced an update on their ongoing clinical study.
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Study Overview: The Inspire Pediatric Post-Approval Registry aims to evaluate the long-term safety and effectiveness of the Inspire Upper Airway Stimulation (UAS) System in pediatric patients aged 18-21 years with moderate to severe obstructive sleep apnea (OSA). This multi-center, single-arm study is significant as it seeks to provide critical data on the system’s performance over a five-year period post-implant.
Intervention/Treatment: The study focuses on the Inspire Upper Airway Stimulation System, a device designed to treat OSA by stimulating the airway muscles to prevent obstruction during sleep.
Study Design: This is an observational cohort study with a prospective time perspective. It does not involve random allocation or masking, as it aims to observe the outcomes of the UAS system in a real-world setting.
Study Timeline: The study began on June 30, 2020, with a primary completion date yet to be announced. The estimated completion date is February 24, 2025, which is also the date of the last update. These dates are crucial for tracking the study’s progress and anticipating results.
Market Implications: The ongoing study could influence Inspire Medical’s stock performance positively, as successful results may enhance investor confidence and market position. The study’s outcomes could also impact the competitive landscape in the OSA treatment market, potentially affecting other companies offering alternative solutions.
The study is currently recruiting, and further details can be accessed on the ClinicalTrials portal.