Surgical Safety Device Use During Transoral Surgery
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Tonsil Disease
- Sponsor
- Nationwide Children's Hospital
- Enrollment
- 250
- Locations
- 1
- Primary Endpoint
- Surgical Field Visibility
- Status
- Enrolling By Invitation
- Last Updated
- 2 years ago
Overview
Brief Summary
The investigators are studying the use of a new medical device developed at Nationwide Children's. This technology has been licensed and produced by Zotarix LLC, a medical device company. It is designed to aid in retraction and provide protection of the lips during surgery. The investigators are not recording any of your identifiable personal health information except for the surgery date. This device, called the LabraGuard is a sterile, soft medical grade silicone, and no alternative device with these exact protective properties exists, and the investigators are trying to learn more about how it performs in different age children.
Investigators
Tendy Chiang
Assistant professor
Nationwide Children's Hospital
Eligibility Criteria
Inclusion Criteria
- •Subjects 21 years of age and under
- •Having a surgical procedure done through the mouth where the lips are at risk of injury
- •Performed by attendings from either the Otolaryngology department or the Dental department.
- •Subject/Subject's guardian provides consent to be in the study
Exclusion Criteria
- •Allergy to silicone
- •Unable to achieve good fit
Outcomes
Primary Outcomes
Surgical Field Visibility
Time Frame: baseline
Surgeons level of visibility of the oropharynx on a scale of 1 to 10