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

January 8, 2025 updated by: Chang Gung Memorial Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taoyuan, Taiwan
        • Linkou Chang Gung Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OSAS with SP Da Vinci
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Conversion rate
Time Frame: 3 months (+60 days) post-surgery
Success of tongue base resection without conversion to alternative surgery
3 months (+60 days) post-surgery
Apena Hypopnea Index
Time Frame: 3 months (+60 days) post-surgery
Type I PSG measurements demonstrating Apena Hypopnea Index (AHI) reduction. An AHI of < 20 events/hour and a reduction in AHI of 50% or greater from baseline levels will be defined as success, when evaluated at 3 months (+60 days) post-surgery. Although it does not meet these criteria, it can be interpreted as an "improved" result when AHI is improved after surgery.
3 months (+60 days) post-surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reoperation rate
Time Frame: 30 days
Reoperation rate
30 days
Readmission rate
Time Frame: 30 days
Readmission rate
30 days
Multi-level surgery
Time Frame: Intraoperative
Multi-level surgery (procedure used)
Intraoperative
Snoring Scale
Time Frame: 3 months (+60 days) post-surgery
Snoring VAS
3 months (+60 days) post-surgery
Operative time
Time Frame: Intraoperative
Operative time (first skin incision to closure of wound)
Intraoperative
Console time
Time Frame: 3 months (+60 days) post-surgery
Console time
3 months (+60 days) post-surgery
Transfusion and estimated blood loss
Time Frame: 3 months (+60 days) post-surgery
Transfusion and estimated blood loss
3 months (+60 days) post-surgery
Length of hospital stay
Time Frame: 3 months (+60 days) post-surgery
Length of hospital stay
3 months (+60 days) post-surgery
Complication rate
Time Frame: 30 days
Rate, intraoperative and/or postoperative, Clavien system
30 days
Perioperative mortality
Time Frame: 30 days
Perioperative mortality
30 days
Volume of resected tissue
Time Frame: 3 months (+60 days) post-surgery
measured using the volume displacement method
3 months (+60 days) post-surgery
Pain score
Time Frame: 3 months (+60 days) post-surgery
Pain score (VAS)
3 months (+60 days) post-surgery
Sleepiness Scale
Time Frame: 3 months (+60 days) post-surgery
Epworth Sleepiness Scale (ESS) and Stanford Sleepiness Scale (SSS) at 3 months (+60 days) post-surgery compared to baseline
3 months (+60 days) post-surgery
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: at 1, 3, 6 months post-surgery
Pittsburgh Sleep Quality Index (PSQI) at 1, 3, 6 months post-surgery compared to baseline.
at 1, 3, 6 months post-surgery
Adverse Events
Time Frame: within 3 months (+60 days) post-surgery
Assessment of all reported adverse events (AE) within 3 months, (+60 days) post-surgery. Summarizing the incidence and frequency of all reported adverse events and categorizing them using CTCAE.
within 3 months (+60 days) post-surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Imaging analysis
Time Frame: 3 months (+60 days) post-surgery
Imaging analysis for resected tissue volume
3 months (+60 days) post-surgery
Percentages of sleep stages
Time Frame: 3 months (+60 days) post-surgery
Percentages of sleep stages (N1, N2, N3, R), at 3 months (+60 days) post-surgery compared to baseline.
3 months (+60 days) post-surgery
Lowest oxygen saturation (LSAT)
Time Frame: 3 months (+60 days) post-surgery
Lowest oxygen saturation (LSAT), at 3 months (+60 days) post-surgery compared to baseline.
3 months (+60 days) post-surgery
Percentages of sleep time
Time Frame: 3 months (+60 days) post-surgery
Percent sleep time below 90% oxygen saturation (ST90) at 3 months (+60 days) post-surgery compared to baseline.
3 months (+60 days) post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2025

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

December 17, 2024

First Submitted That Met QC Criteria

January 8, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 8, 2025

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 113-01382A3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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