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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04795817
• Other study ID #: dV SP-TORS OSA
• Status: Completed
• Start date: January 27, 2021
• Est. completion date: January 25, 2023

Study information

• Verified date: May 2023
• Source: Intuitive Surgical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: January 25, 2023
• Est. primary completion date: January 25, 2023
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Intuitive Surgical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Type 1 Polysomnography (PSG)	Type I PSG measurements demonstrating Apnea Hypopnea Index (AHI) reduction.	Pre-operative (within 12 months prior to surgery)
Primary	Type 1 Polysomnography (PSG)	Type I PSG measurements demonstrating Apnea Hypopnea Index (AHI) reduction.	90-150 days after surgery
Secondary	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
Secondary	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
Secondary	Estimated blood loss (EBL)	defined as the estimated amount of blood loss	Intra-Operative Assessment
Secondary	Postoperative hemorrhage	categorized using the Common Terminology Criteria for Adverse Events (CTCAE) v4.03	Intra-Operative Assessment
Secondary	Blood transfusions	defined as whether a blood transfusion was applied or not.	Intra-Operative Assessment
Secondary	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
Secondary	Volume of resected tissue	measured using the volume displacement method	Immediately after surgery
Secondary	Conversion rate	from da Vinci SP surgery to any alternate method required to complete the indicated procedure.	Intra-Operative Assessment
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in Berlin Questionnaire	at 3 months (+60days) compared to baseline	Pre-operative Assessments & Post-Operative (3 months, +60 days) Assessment
Secondary	Change in MDADI (MD Anderson Dysphagia Inventory)	at 3 months (+60days) compared to baseline	Pre-operative Assessments & Post-Operative (3 months, +60 days) Assessment
Secondary	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)
Secondary	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