NCT04795817

Treatment of Obstructive Sleep Apnea (OSA) With the da Vinci® SP™ Surgical System

A Prospective Single Center Investigation of the da Vinci® SP™ Surgical System for Transoral Robotic Surgery (TORS) for Treatment of Obstructive Sleep Apnea (OSA)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 25 (actual)
• Sponsor: Intuitive Surgical · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: —

Summary

It is a prospective, single center, single-arm clinical study to enroll a maximum of 25 subjects.

Detailed description

It is a prospective, single center, single-arm clinical study to enroll a maximum of 25 subjects. The objective of this study is to evaluate the clinical utility of the da Vinci® SP™ Surgical System, instruments and accessories in TORS benign base of tongue resection procedures for the treatment of moderate to severe OSA. da Vinci® SP™ Surgical System, instruments and accessories are the approved medical device product by MFDS (Ministry of Food and Drug Safety, Republic of Korea).

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DEVICE	Transoral Robotic Surgery	Subjects will undergo TORS benign base of tongue resection procedures (i.e., partial glossectomy, epiglottoplasty, epiglottectomy, and/or lingual tonsillectomy) for the treatment of OSA. Concomitant non-robotic surgical procedures may also be performed as part of the subject's treatment for OSA, and can include one or more of the following: uvulopalatopharyngoplasty (UPPP), lateral pharyngoplasty, expansion sphincter pharyngoplasty, palatine tonsillectomy, or a modified uvulopalatoplasty. Nasal surgery such as septoplasty or turbinoplasty can be combined if it is needed.

Timeline

• Start date: 2021-01-27
• Primary completion: 2023-01-25
• Completion: 2023-01-25
• First posted: 2021-03-12
• Last updated: 2023-05-31

Locations

1 site across 1 country: South Korea