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)

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

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).

Inclusion Criteria:

• Subject is between 18 and 80 years old
• Subject with BMI ≤ 35
• Subject with moderate to severe sleep apnea, defined as 15 or more AHI events/hour
• Subject who has failed or is unable to tolerate CPAP therapy
• Subject diagnosed with OSA due to redundant base of tongue tissue
• Subject must be a suitable candidate for base of tongue resection surgery
• Subject who is willing and able to provide written informed consent
• Subject who is willing and able to comply with the study protocol requirements

Exclusion Criteria:

• Subject with a poor mouth opening or trismus
• Subject with evidence of any primary cancers or metastatic disease, other than skin cancers
• Subject who has had a surgical resection and/or chemoradiation therapy for oropharyngeal cancer
• Subject with congenital malformations in the larynx, throat or tongue
• Subject with an American Society of Anesthesiologists (ASA) score of Grade 4 or above during preoperative evaluation
• Subject for whom any additional surgeries are planned for OSA within the study period, after the surgery in which the da Vinci SP System was used
• Subject who is mentally handicapped or with a psychological disorder or severe systemic illness, that would preclude compliance with study requirements or ability to provide informed consent
• Subject is pregnant or suspected to be pregnant