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

Intuitive Surgical25 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Obstructive Sleep Apnea

Interventions

Transoral Robotic SurgeryDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Outcomes

Primary Outcomes

Type 1 Polysomnography (PSG)

Type I PSG measurements demonstrating Apnea Hypopnea Index (AHI) reduction.

Time frame: Pre-operative (within 12 months prior to surgery)

Type 1 Polysomnography (PSG)

Type I PSG measurements demonstrating Apnea Hypopnea Index (AHI) reduction.

Time frame: 90-150 days after surgery

Secondary Outcomes

Total operative time

defined as the time the patient spends in the operating room (OR), i.e. OR "In and Out" time. This includes the patient prep time, anesthesia time, robotic docking time, robotic procedure time and time taken for non-robotic concomitant procedures, which are part of the multi-level surgical treatment approach for that particular patient.