Clinical trial NCT06766760: Surgical Treatment for Patients With Obstructive Sleep Apnea by Using Da Vinci SP Surgical System
Official title: A Pilot Study of Single-port Robot-assisted Surgery Using da Vinci SP Surgical System for the Surgical Treatment for Patients With Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2025-01-09
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: This study will be conducted in Chang Gung Memorial Hospital at Linkou.

Informed consent will be provided to patient who has an indication of surgical treatment for OSA. Study participants will sign an informed consent before any study procedure begins. Eligibilities will be assessed during screening period (2 weeks) with blood test and other routine assessments. Eligible patient will undergo surgical intervention using da Vinci SP Surgical System. Post-operation follow-up will be performed at 1 week, 1 month, 3 months, and 6 months.

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

Primary outcomes:
measure: Conversion rate
timeFrame: 3 months (+60 days) post-surgery
measure: Apena Hypopnea Index
timeFrame: 3 months (+60 days) post-surgery
Secondary outcomes:
measure: Multi-level surgery
timeFrame: Intraoperative
measure: Snoring Scale
timeFrame: 3 months (+60 days) post-surgery
measure: Operative time
timeFrame: Intraoperative
measure: Console time
timeFrame: 3 months (+60 days) post-surgery
measure: Transfusion and estimated blood loss
timeFrame: 3 months (+60 days) post-surgery
measure: Length of hospital stay
timeFrame: 3 months (+60 days) post-surgery
measure: Complication rate
timeFrame: 30 days
measure: Readmission rate
timeFrame: 30 days
measure: Reoperation rate
timeFrame: 30 days
measure: Perioperative mortality
timeFrame: 30 days
measure: Volume of resected tissue
timeFrame: 3 months (+60 days) post-surgery
measure: Pain score
timeFrame: 3 months (+60 days) post-surgery
measure: Sleepiness Scale
timeFrame: 3 months (+60 days) post-surgery
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: at 1, 3, 6 months post-surgery
measure: Adverse Events
timeFrame: within 3 months (+60 days) post-surgery
Other outcomes:
measure: Imaging analysis
timeFrame: 3 months (+60 days) post-surgery
measure: Percentages of sleep stages
timeFrame: 3 months (+60 days) post-surgery
measure: Lowest oxygen saturation (LSAT)
timeFrame: 3 months (+60 days) post-surgery
measure: Percentages of sleep time
timeFrame: 3 months (+60 days) post-surgery
Locations:
city: Taoyuan
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital
Study officials:
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