Oral Device Clinical Trial

Nationwide Children's Hospital

Status and phase: Invitation-only; Phase 1

Conditions: Adenoid; Disorder (and Tonsils); Tonsil Disease; Dental Diseases

Treatments: Device: LabraGuard

Study type: Interventional

Funder types: Other

Identifiers

NCT05022368

STUDY00000722

Details and patient eligibility

About

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.

Enrollment: 250 estimated patients

Sex: All

Ages: Under 21 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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250 participants in 1 patient group

Oral Safety Device

Experimental group

Description:

patients on which the device "LabraGuard" is used.

Treatment:

Device: LabraGuard