Obstructive Sleep Apnea
Conditions
Keywords
OSA
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).
Interventions
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.
Sponsors
Intuitive Surgical
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Type 1 Polysomnography (PSG) | Pre-operative (within 12 months prior to surgery) | Type I PSG measurements demonstrating Apnea Hypopnea Index (AHI) reduction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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) |
| Volume of resected tissue | Immediately after surgery | measured using the volume displacement method |
| 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 Epworth Sleepiness Scale (ESS) | Pre-operative Assessments & Post-Operative (3 months +60 days) Assessment | at 3 months (+60 days) post-surgery compared to baseline |
| 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 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 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 Berlin Questionnaire | Pre-operative Assessments & Post-Operative (3 months, +60 days) Assessment | at 3 months (+60days) 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 |
| 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 |
| 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 |
| 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 |
Countries
South Korea
Outcome results
None listed