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

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: Transoral Robotic Surgery

• Registration Number: NCT04795817
• Lead Sponsor: Intuitive Surgical

Brief Summary

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

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 Timeline

• Study Start: 2021-01-27
• Study First Submitted: 2021-02-01
• Study First Submitted QC: 2021-03-09
• Study First Posted: 2021-03-12
• Primary Completion: 2023-01-25
• Study Completion: 2023-01-25
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-26
• Last Update Posted: 2023-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Single arm	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

Primary Outcome Measures

Name	Time	Method
Type 1 Polysomnography (PSG)	90-150 days after surgery	Type I PSG measurements demonstrating Apnea Hypopnea Index (AHI) reduction.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Severance Hospital, Yonsei University Health System; 🇰🇷 Seoul, Korea, Republic of