Oral Device Clinical Trial
- Conditions
- Dental DiseasesAdenoid; Disorder (and Tonsils)Tonsil Disease
- Interventions
- Device: LabraGuard
- Registration Number
- NCT05022368
- Lead Sponsor
- Nationwide Children's Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 250
- 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
- Allergy to silicone
- Unable to achieve good fit
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Oral Safety Device LabraGuard patients on which the device "LabraGuard" is used.
- Primary Outcome Measures
Name Time Method Surgical Field Visibility baseline Surgeons level of visibility of the oropharynx on a scale of 1 to 10
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States