Treatment of Obstructive Sleep Apnea (OSA) With the da Vinci® SP™ Surgical System

NCT04795817 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 25

Last updated 2023-05-31

No results posted yet for this study

Summary

It is a prospective, single center, single-arm clinical study to enroll a maximum of 25 subjects.

Conditions

Interventions

DEVICE

Transoral Robotic Surgery

Subjects will undergo TORS benign base of tongue resection procedures (i.e., partial glossectomy, epiglottoplasty, epiglottectomy, and/or lingual tonsillectomy) for the treatment of OSA. Concomitant non-robotic surgical procedures may also be performed as part of the subject's treatment for OSA, and can include one or more of the following: uvulopalatopharyngoplasty (UPPP), lateral pharyngoplasty, expansion sphincter pharyngoplasty, palatine tonsillectomy, or a modified uvulopalatoplasty. Nasal surgery such as septoplasty or turbinoplasty can be combined if it is needed.

Sponsors & Collaborators

  • Intuitive Surgical

    lead INDUSTRY

Principal Investigators

  • HyungJu Cho, M.D., Ph.D. · Severance Hospital, Yonsei University Health System

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-27
Primary Completion
2023-01-25
Completion
2023-01-25

Countries

  • South Korea

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04795817 on ClinicalTrials.gov