Surgical Treatment for Patients With Obstructive Sleep Apnea by Using Da Vinci SP Surgical System

NCT06766760 | Not Yet Recruiting FDA Device

• 1 other identifier: 113-01382A3
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, interventional, non-randomized, single arm, clinical trial will investigate feasibility and safety of trans-oral robotic surgery using da Vinci SP Surgical System in Taiwan for the surgical treatment of OSA. All the investigators are well trained and have received proof of training after completing the training program for da Vinci SP system provided by Intuitive.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (2)

• Conversion rate

  Success of tongue base resection without conversion to alternative surgery

  3 months (+60 days) post-surgery

• Apena Hypopnea Index

  Type I PSG measurements demonstrating Apena Hypopnea Index (AHI) reduction. An AHI of \< 20 events/hour and a reduction in AHI of 50% or greater from baseline levels will be defined as success, when evaluated at 3 months (+60 days) post-surgery. Although it does not meet these criteria, it can be interpreted as an "improved" result when AHI is improved after surgery.

  3 months (+60 days) post-surgery

Secondary Outcomes (15)

• Multi-level surgery

  Intraoperative

• Snoring Scale

  3 months (+60 days) post-surgery

• Operative time

  Intraoperative

• Console time

  3 months (+60 days) post-surgery

• Transfusion and estimated blood loss

  3 months (+60 days) post-surgery

Other Outcomes (4)

• Imaging analysis

  3 months (+60 days) post-surgery

• Percentages of sleep stages

  3 months (+60 days) post-surgery

• Lowest oxygen saturation (LSAT)

  3 months (+60 days) post-surgery

Study Arms (1)

OSAS with SP Da Vinci

EXPERIMENTAL

Device: Da Vinci SP Surgical System, Model SP1098

Interventions

Da Vinci SP Surgical System, Model SP1098 DEVICE

The da Vinci SP Surgical System is intended to assist in the accurate control of the da Vinci SP endoscope and instruments during minimally invasive endoscopic abdominopelvic, thoracoscopic, transoral otolaryngology, and breast surgical procedures. The system is indicated for adult use. It is intended to be used by trained physicians in an operating room environment.

OSAS with SP Da Vinci

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or more.
• OSA with AHI ≥ 15
• Has failed, refuses, or is unable to tolerate CPAP therapy
• Indication of resection of tongue base with/without other invasive surgical procedure for OSA (i.e. tongue base resection only or multi-level surgery with tongue base resection)
• ASA physical status classification 1-2 and adequate organ function
• Patients willing and able to comply with study protocol requirements and follow-up
• Informed consent

You may not qualify if:

• BMI\>35
• Mouth opening too narrow for TORS or trismus
• Betel nut chewing
• Suspicious cancer diagnosis
• Prior head-and-neck surgery (note: prior invasive therapy for OSA allowed)
• Other medical condition or anatomical factor not suitable for TORS, including subject with congenital malformations in the larynx, throat or tongue; 1. Subject with an American Society of Anesthesiologists (ASA) score of Grade 4 or above during preoperative evaluation
• Active infectious disease
• Can't follow trial-required procedures
• Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic interventions
• Severe heart disease (NYHA functional class III-IV)
• Severe lung disease (GOLD Group C-D)
• Long-term use of anti-coagulant
• Patients with coagulopathy
• Emergency surgery
• 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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Linkou Chang Gung Memorial Hospital

Taoyuan District, Taiwan

Location

Related Publications (28)

• Costantino A, Sampieri C, Meliante PG, De Virgilio A, Kim SH. Transoral robotic surgery in oropharyngeal squamous cell carcinoma: A comparative study between da Vinci Single-Port and da Vinci Xi systems. Oral Oncol. 2024 Jan;148:106629. doi: 10.1016/j.oraloncology.2023.106629. Epub 2023 Nov 14.

  PMID: 37972462 RESULT

• Baptista PM, Diaz Zufiaurre N, Garaycochea O, Alcalde Navarrete JM, Moffa A, Giorgi L, Casale M, O'Connor-Reina C, Plaza G. TORS as Part of Multilevel Surgery in OSA: The Importance of Careful Patient Selection and Outcomes. J Clin Med. 2022 Feb 14;11(4):990. doi: 10.3390/jcm11040990.

  PMID: 35207264 RESULT

• Lin HC, Friedman M. Transoral robotic OSA surgery. Auris Nasus Larynx. 2021 Jun;48(3):339-346. doi: 10.1016/j.anl.2020.08.025. Epub 2020 Sep 8.

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• Park YM, Kim DH, Kang MS, Lim JY, Choi EC, Koh YW, Kim SH. The First Human Trial of Transoral Robotic Surgery Using a Single-Port Robotic System in the Treatment of Laryngo-Pharyngeal Cancer. Ann Surg Oncol. 2019 Dec;26(13):4472-4480. doi: 10.1245/s10434-019-07802-0. Epub 2019 Sep 9.

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• Chen MM, Orosco RK, Lim GC, Holsinger FC. Improved transoral dissection of the tongue base with a next-generation robotic surgical system. Laryngoscope. 2018 Jan;128(1):78-83. doi: 10.1002/lary.26649. Epub 2017 Jul 6.

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• Maurice MJ, Kaouk JH. Single-Port Robot-Assisted Perineal Prostatectomy and Pelvic Lymphadenectomy: Step-by-Step Technique in a Cadaveric Model. J Endourol. 2018 May;32(S1):S93-S96. doi: 10.1089/end.2017.0707.

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• Lan WC, Chang WD, Tsai MH, Tsou YA. Trans-oral robotic surgery versus coblation tongue base reduction for obstructive sleep apnea syndrome. PeerJ. 2019 Oct 2;7:e7812. doi: 10.7717/peerj.7812. eCollection 2019.

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• Tsou YA, Hsu CC, Shih LC, Lin TC, Chiu CJ, Tien VH, Tsai MH, Chang WD. Combined Transoral Robotic Tongue Base Surgery and Palate Surgery in Obstructive Sleep Apnea Syndrome: Modified Uvulopalatopharyngoplasty versus Barbed Reposition Pharyngoplasty. J Clin Med. 2021 Jul 18;10(14):3169. doi: 10.3390/jcm10143169.

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MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Tuan-Jen Fang

CONTACT

+886-3-32801200; fang3109@cgmh.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: January 9, 2025
• Study Start: January 1, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 9, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)