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

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

Detailed Description
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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).

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

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Device: Transoral Robotic Surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Single arm<br>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 | Device: Transoral Robotic Surgery<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type 1 Polysomnography (PSG) | Type I PSG measurements demonstrating Apnea Hypopnea Index (AHI) reduction. | Pre-operative (within 12 months prior to surgery) | 
| Type 1 Polysomnography (PSG) | Type I PSG measurements demonstrating Apnea Hypopnea Index (AHI) reduction. | 90-150 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Intra-Operative Assessment | 
| Robotic procedure time | defined as time from docking the robot at the initiation of surgery to undocking at the completion of surgery. | Intra-Operative Assessment | 
| Estimated blood loss (EBL) | defined as the estimated amount of blood loss | Intra-Operative Assessment | 
| Postoperative hemorrhage | categorized using the Common Terminology Criteria for Adverse Events (CTCAE) v4.03 | Intra-Operative Assessment | 
| Blood transfusions | defined as whether a blood transfusion was applied or not. | Intra-Operative Assessment | 
| Length of hospital stay (LOS) | Duration of hospital say(from admission to discharge) | Admission to the hospital to discharge from the hospital (check out time), up to an approximate of one week | 
| Volume of resected tissue | measured using the volume displacement method | Immediately after surgery | 
| Conversion rate | from da Vinci SP surgery to any alternate method required to complete the indicated procedure. | Intra-Operative Assessment | 
| Change in Apnea index (AI) | at 3 months (+60 days) post-surgery compared to baseline | Pre-operative Assessments & Post-Operative (3 months +60 days) Assessment | 
| Change in Hypopnea index (HI) | at 3 months (+60 days) post-surgery compared to baseline | Pre-operative Assessments & Post-Operative (3 months +60 days) Assessment | 
| Change in Percentages of sleep stages (N1, N2, N3, R) | at 3 months (+60 days) post-surgery compared to baseline | Pre-operative Assessments & Post-Operative (3 months +60 days) Assessment | 
| Change in Lowest oxygen saturation (LSAT) | at 3 months (+60 days) post-surgery compared to baseline | Pre-operative Assessments & Post-Operative (3 months +60 days) Assessment | 
| Change in Percent sleep time below 90 percent oxygen saturation (ST90) | at 3 months (+60 days) post-surgery compared to baseline | Pre-operative Assessments & Post-Operative (3 months +60 days) Assessment | 
| Change in Epworth Sleepiness Scale (ESS) | at 3 months (+60 days) post-surgery compared to baseline | Pre-operative Assessments & Post-Operative (3 months +60 days) Assessment | 
| Change in Stanford Sleepiness Scale (SSS) | at 3 months (+60 days) post-surgery compared to baseline | Pre-operative Assessments & Post-Operative (3 months, +60 days) Assessment | 
| Change in Berlin Questionnaire | at 3 months (+60days) compared to baseline | Pre-operative Assessments & Post-Operative (3 months, +60 days) Assessment | 
| Change in MDADI (MD Anderson Dysphagia Inventory) | at 3 months (+60days) compared to baseline | Pre-operative Assessments & Post-Operative (3 months, +60 days) Assessment | 
| Adverse Events (AE) | Assessment of all reported adverse events (AE) within 3 months +60 days (90-150 days) post-surgery. Summarizing the incidence and frequency of all reported adverse events and categorizing them using CTCAE v4.03 | Through study conclusion (3 month follow up +60 days) | 
| Change in Upper airway volume | measured by CT scan as optional | Pre-operative Assessment, Post-operative (within 30days ±14 days from surgery) Assessment & Post-Operative (3 months, +60 days) Assessment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OSA