NCT02094482

Prospective Evaluation of a New Palatal Implant for Treatment of Snoring and Obstructive Sleep Apnea (OSAS)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Medartis AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Prospective Evaluation of a New Palatal Implant for Treatment of Snoring and Obstructive Sleep Apnea (OSAS)

Detailed description

The new OSAS Implant is intended for use in the palate (hard and soft palate/ see picture above) in order to stiffen and stabilize the soft palate, which may reduce the severity of airway obstructions and of snoring in patients suffering from OSA (Obstructive Sleep Apnea). Indications for use of the System include: symptomatic, habitual, social snoring due to palatal flutter or upper airway obstruction primarily caused by the retropalatal obstruction. The System is labeled for use by physicians only. The primary endpoint is the Apnea-Hypopnea-Index (AHI) in the 90 days follow-up. Study hypothesis: Reduction of initial AHI ≥20%

Conditions

• Reduction of Initial AHI
• Reduction of Initial Snoaring Index

Interventions

Type	Name	Description
DEVICE	The IMD is a resilient palatal implant which is introduced through a stab incision into the palate.	The IMD is a resilient palatal implant which is introduced through a stab incision into the palate. Two implants are placed underneath the rostral part of the palatal bone and continue into the upper part of the soft palate

Timeline

• Start date: 2014-04-01
• Primary completion: 2020-07-01
• Completion: 2020-10-01
• First posted: 2014-03-21
• Last updated: 2021-09-13

Locations

1 site across 1 country: Switzerland