Clinical trial NCT04795817: Treatment of Obstructive Sleep Apnea (OSA) With the da Vinci® SP™ Surgical System
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea
Keywords: OSA
Lead sponsor: Intuitive Surgical
Sponsor class: INDUSTRY
First posted: 2021-03-12
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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).

Eligibility criteria: 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

Primary outcomes:
measure: Type 1 Polysomnography (PSG)
timeFrame: Pre-operative (within 12 months prior to surgery)
measure: Type 1 Polysomnography (PSG)
timeFrame: 90-150 days after surgery
Secondary outcomes:
measure: Total operative time
timeFrame: Intra-Operative Assessment
measure: Robotic procedure time
timeFrame: Intra-Operative Assessment
measure: Estimated blood loss (EBL)
timeFrame: Intra-Operative Assessment
measure: Postoperative hemorrhage
timeFrame: Intra-Operative Assessment
measure: Blood transfusions
timeFrame: Intra-Operative Assessment
measure: Length of hospital stay (LOS)
timeFrame: Admission to the hospital to discharge from the hospital (check out time), up to an approximate of one week
measure: Volume of resected tissue
timeFrame: Immediately after surgery
measure: Conversion rate
timeFrame: Intra-Operative Assessment
measure: Change in Apnea index (AI)
timeFrame: Pre-operative Assessments & Post-Operative (3 months +60 days) Assessment
measure: Change in Hypopnea index (HI)
timeFrame: Pre-operative Assessments & Post-Operative (3 months +60 days) Assessment
measure: Change in Percentages of sleep stages (N1, N2, N3, R)
timeFrame: Pre-operative Assessments & Post-Operative (3 months +60 days) Assessment
measure: Change in Lowest oxygen saturation (LSAT)
timeFrame: Pre-operative Assessments & Post-Operative (3 months +60 days) Assessment
measure: Change in Percent sleep time below 90 percent oxygen saturation (ST90)
timeFrame: Pre-operative Assessments & Post-Operative (3 months +60 days) Assessment
measure: Change in Epworth Sleepiness Scale (ESS)
timeFrame: Pre-operative Assessments & Post-Operative (3 months +60 days) Assessment
measure: Change in Stanford Sleepiness Scale (SSS)
timeFrame: Pre-operative Assessments & Post-Operative (3 months, +60 days) Assessment
measure: Change in Berlin Questionnaire
timeFrame: Pre-operative Assessments & Post-Operative (3 months, +60 days) Assessment
measure: Change in MDADI (MD Anderson Dysphagia Inventory)
timeFrame: Pre-operative Assessments & Post-Operative (3 months, +60 days) Assessment
measure: Adverse Events (AE)
timeFrame: Through study conclusion (3 month follow up +60 days)
measure: Change in Upper airway volume
timeFrame: Pre-operative Assessment, Post-operative (within 30days ±14 days from surgery) Assessment & Post-Operative (3 months, +60 days) Assessment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
Study officials:
affiliation: Severance Hospital, Yonsei University Health System
name: HyungJu Cho, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: