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Completed

NCT Number: NCT04795817

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

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

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

About this study

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).

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transoral robotic surgery

Device

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.

Primary outcomes

  1. Type 1 Polysomnography (PSG)

    Time frame: Pre-operative (within 12 months prior to surgery)

    Type I PSG measurements demonstrating Apnea Hypopnea Index (AHI) reduction.

  2. Type 1 Polysomnography (PSG)

    Time frame: 90-150 days after surgery

    Type I PSG measurements demonstrating Apnea Hypopnea Index (AHI) reduction.

Secondary outcomes

  1. Total operative time

    Time frame: 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.

  2. Robotic procedure time

    Time frame: Intra-Operative Assessment

    defined as time from docking the robot at the initiation of surgery to undocking at the completion of surgery.

  3. Estimated blood loss (EBL)

    Time frame: Intra-Operative Assessment

    defined as the estimated amount of blood loss

  4. Postoperative hemorrhage

    Time frame: Intra-Operative Assessment

    categorized using the Common Terminology Criteria for Adverse Events (CTCAE) v4.03

  5. Blood transfusions

    Time frame: Intra-Operative Assessment

    defined as whether a blood transfusion was applied or not.

  6. Length of hospital stay (LOS)

    Time frame: 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)

  7. Volume of resected tissue

    Time frame: Immediately after surgery

    measured using the volume displacement method

  8. Conversion rate

    Time frame: Intra-Operative Assessment

    from da Vinci SP surgery to any alternate method required to complete the indicated procedure.

  9. Change in Apnea index (AI)

    Time frame: Pre-operative Assessments & Post-Operative (3 months +60 days) Assessment

    at 3 months (+60 days) post-surgery compared to baseline

  10. Change in Hypopnea index (HI)

    Time frame: Pre-operative Assessments & Post-Operative (3 months +60 days) Assessment

    at 3 months (+60 days) post-surgery compared to baseline

  11. Change in Percentages of sleep stages (N1, N2, N3, R)

    Time frame: Pre-operative Assessments & Post-Operative (3 months +60 days) Assessment

    at 3 months (+60 days) post-surgery compared to baseline

  12. Change in Lowest oxygen saturation (LSAT)

    Time frame: Pre-operative Assessments & Post-Operative (3 months +60 days) Assessment

    at 3 months (+60 days) post-surgery compared to baseline

  13. Change in Percent sleep time below 90 percent oxygen saturation (ST90)

    Time frame: Pre-operative Assessments & Post-Operative (3 months +60 days) Assessment

    at 3 months (+60 days) post-surgery compared to baseline

  14. Change in Epworth Sleepiness Scale (ESS)

    Time frame: Pre-operative Assessments & Post-Operative (3 months +60 days) Assessment

    at 3 months (+60 days) post-surgery compared to baseline

  15. Change in Stanford Sleepiness Scale (SSS)

    Time frame: Pre-operative Assessments & Post-Operative (3 months, +60 days) Assessment

    at 3 months (+60 days) post-surgery compared to baseline

  16. Change in Berlin Questionnaire

    Time frame: Pre-operative Assessments & Post-Operative (3 months, +60 days) Assessment

    at 3 months (+60days) compared to baseline

  17. Change in MDADI (MD Anderson Dysphagia Inventory)

    Time frame: Pre-operative Assessments & Post-Operative (3 months, +60 days) Assessment

    at 3 months (+60days) compared to baseline

  18. Adverse Events (AE)

    Time frame: 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

  19. Change in Upper airway volume

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Intuitive Surgical

Industry

Registry information

Official study 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)

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 12, 2021
Registry last updated
May 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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