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

NCT04795817 | Completed

• 1 other identifier: dV SP-TORS OSA
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obstructive Sleep Apnea

Keywords

OSA

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (19)

• Total operative time

  Intra-Operative Assessment

• Robotic procedure time

  Intra-Operative Assessment

• Estimated blood loss (EBL)

  Intra-Operative Assessment

• Postoperative hemorrhage

  Intra-Operative Assessment

• Blood transfusions

  Intra-Operative Assessment

Study Arms (1)

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

Device: Transoral Robotic Surgery

Interventions

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.

Single arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Intuitive Surgical: lead

Study Sites (1)

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

Location

Related Publications (1)

• 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.

  PMID: 39576059 DERIVED

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

Study Officials

• HyungJu Cho, M.D., Ph.D.

  Severance Hospital, Yonsei University Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2021
• First Posted: March 12, 2021
• Study Start: January 27, 2021
• Primary Completion: January 25, 2023
• Study Completion: January 25, 2023
• Last Updated: May 31, 2023

Record last verified: 2023-05

Locations

KR (1)