NCT06766760

Surgical Treatment for Patients With Obstructive Sleep Apnea by Using Da Vinci SP Surgical System

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DEVICE	Da Vinci SP Surgical System, Model SP1098	The da Vinci SP Surgical System is intended to assist in the accurate control of the da Vinci SP endoscope and instruments during minimally invasive endoscopic abdominopelvic, thoracoscopic, transoral otolaryngology, and breast surgical procedures. The system is indicated for adult use. It is intended to be used by trained physicians in an operating room environment.

Timeline

• Start date: 2025-01-01
• Primary completion: 2025-12-01
• Completion: 2026-06-01
• First posted: 2025-01-09
• Last updated: 2025-01-09

Locations

1 site across 1 country: Taiwan

Regulatory

• FDA-regulated device study