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It is a prospective, single center, single-arm clinical study to enroll a maximum of 25 subjects.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Type 1 Polysomnography (PSG) | Type I PSG measurements demonstrating Apnea Hypopnea Index (AHI) reduction. | Pre-operative (within 12 months prior to surgery) |
| Type 1 Polysomnography (PSG) | Type I PSG measurements demonstrating Apnea Hypopnea Index (AHI) reduction. | 90-150 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| HyungJu Cho, M.D., Ph.D. | Severance Hospital, Yonsei University Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Hospital, Yonsei University Health System | Seoul | 03722 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39576059 | Derived | Jeong Y, Rha MS, Kim CH, Cho HJ. First Prospective Study on Single-Port Robotic Tongue Base Resection for Sleep Apnea. Head Neck. 2025 Apr;47(4):1071-1078. doi: 10.1002/hed.28007. Epub 2024 Nov 22. |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| 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 |
| Estimated blood loss (EBL) | defined as the estimated amount of blood loss | Intra-Operative Assessment |
| Postoperative hemorrhage | categorized using the Common Terminology Criteria for Adverse Events (CTCAE) v4.03 | Intra-Operative Assessment |
| Blood transfusions | defined as whether a blood transfusion was applied or not. | Intra-Operative Assessment |
| 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 |
| Volume of resected tissue | measured using the volume displacement method | Immediately after surgery |
| Conversion rate | from da Vinci SP surgery to any alternate method required to complete the indicated procedure. | Intra-Operative Assessment |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Change in Berlin Questionnaire | at 3 months (+60days) compared to baseline | Pre-operative Assessments & Post-Operative (3 months, +60 days) Assessment |
| Change in MDADI (MD Anderson Dysphagia Inventory) | at 3 months (+60days) compared to baseline | Pre-operative Assessments & Post-Operative (3 months, +60 days) Assessment |
| 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) |
| 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 |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |