Oral Device Clinical Trial

Nationwide Children's Hospital250 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

250

Conditions

Tonsil Disease Dental Diseases Adenoid; Disorder (and Tonsils)

Interventions

Protection of the lips and the oral commissure during transoral procedures

Eligibility

Sex: ALLMax age: 21 Years

Medical Language ↔ Plain English

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

Locations (1)

Nationwide Children's Hospital

Columbus, Ohio, United States

Outcomes

Primary Outcomes

Surgical Field Visibility

Surgeons level of visibility of the oropharynx on a scale of 1 to 10

Time frame: baseline

Data from ClinicalTrials.gov

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