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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-27

Study Completion Date

2023-01-25

Brief Summary

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

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Detailed Description

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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).

Conditions

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Obstructive Sleep Apnea

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Transoral Robotic Surgery

Intervention Type 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.

Interventions

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Transoral Robotic Surgery

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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No