Oral Device Clinical Trial

Surgical Safety Device Use During Transoral Surgery

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 Overview

• Status: Enrolling by invitation
• Conditions: Dental Diseases; Tonsil Disease; Adenoid; Disorder (and Tonsils)
• Intervention / Treatment: Device: LabraGuard

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 21 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral Safety Device; patients on which the device "LabraGuard" is used.	Device: LabraGuard; Protection of the lips and the oral commissure during transoral procedures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical Field Visibility	Surgeons level of visibility of the oropharynx on a scale of 1 to 10	baseline

Collaborators and Investigators

• Sponsor: Nationwide Children's Hospital
• Collaborators: Zotarix LLC

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2021
• Primary Completion (Actual): August 1, 2022
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: August 25, 2021
• First Submitted That Met QC Criteria: August 25, 2021
• First Posted (Actual): August 26, 2021

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 11, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases
• Other Study ID Numbers: STUDY00000722

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No