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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Device: Transoral Robotic Surgery

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).

• Study Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

• Study Contact: Name: ChunSik Eum; Phone Number: +82-10-3239-0878; Email: chunsik.eum@intusurg.com
• Study Contact Backup: Name: Shilpa Mehendale; Phone Number: +1-408-523-8869; Email: shilpa.mehendale@intusurg.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital, Yonsei University Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

• Subject who has failed or is unable to tolerate CPAP therapy
• Subject who is diagnosed with OSA due to redundant base of tongue tissue
• Subject who has moderate to severe sleep apnea, defined as 15 or more AHI events/hour
• Subject who has planned a tongue base resection surgery

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Single arm; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Intuitive Surgical
• Investigators: Principal Investigator: HyungJu Cho, M.D., Ph.D., Severance Hospital, Yonsei University Health System

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2021
• Primary Completion (Actual): January 25, 2023
• Study Completion (Actual): January 25, 2023

Study Registration Dates

• First Submitted: February 1, 2021
• First Submitted That Met QC Criteria: March 9, 2021
• First Posted (Actual): March 12, 2021

Study Record Updates

• Last Update Posted (Actual): May 31, 2023
• Last Update Submitted That Met QC Criteria: May 26, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: OSA
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: dV SP-TORS OSA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes