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

Intuitive Surgical

Status: Completed

Conditions: Obstructive Sleep Apnea

Treatments: Device: Transoral Robotic Surgery

Study type: Observational

Funder types: Industry

Identifiers

NCT04795817

dV SP-TORS OSA

Details and patient eligibility

About

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

Full 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).

Enrollment: 25 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

25 participants in 1 patient group

Single arm

Description:

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

Treatment:

Device: Transoral Robotic Surgery