Adenoid; Disorder (and Tonsils), Dental Diseases, Tonsil Disease
Conditions
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.
Interventions
DEVICELabraGuard
Protection of the lips and the oral commissure during transoral procedures
Sponsors
Zotarix LLC
Nationwide Children's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 21 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Surgical Field Visibility | baseline | Surgeons level of visibility of the oropharynx on a scale of 1 to 10 |
Countries
United States
Outcome results
None listed