Status:
COMPLETED
Treatment of Obstructive Sleep Apnea (OSA) With the da Vinci® SP™ Surgical System
Lead Sponsor:
Intuitive Surgical
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
18-80 years
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, ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 27 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 25 2023
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04795817
Start Date
January 27 2021
End Date
January 25 2023
Last Update
May 31 2023
Active Locations (1)
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1
Severance Hospital, Yonsei University Health System
Seoul, South Korea, 03722