Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-25 @ 2:12 AM
NCT ID:
NCT06766760
Eligibility Criteria:
Inclusion Criteria:
1. Age 18 years or more.
2. OSA with AHI ≥ 15
3. Has failed, refuses, or is unable to tolerate CPAP therapy
4. 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)
5. ASA physical status classification 1-2 and adequate organ function
6. Patients willing and able to comply with study protocol requirements and follow-up
7. Informed consent
Exclusion Criteria:
1. BMI\>35
2. Mouth opening too narrow for TORS or trismus
3. Betel nut chewing
4. Suspicious cancer diagnosis
5. Prior head-and-neck surgery (note: prior invasive therapy for OSA allowed)
6. 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
7. Active infectious disease
8. Can't follow trial-required procedures
9. 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)
10. Long-term use of anti-coagulant
11. Patients with coagulopathy
12. Emergency surgery
13. 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
14. Subject is pregnant or suspected to be pregnant
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06766760
Study Brief:
Protocol Section:
NCT06766760