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NCT05022368 Clinical Trial

Oral Device Clinical Trial

Dental Diseases Clinical Trial

Official title:
Surgical Safety Device Use During Transoral Surgery

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05022368
Other study ID # STUDY00000722
Secondary ID
Status Enrolling by invitation
Phase Phase 1
First received
Last updated
Start date May 24, 2021
Est. completion date August 1, 2024

Study information
Verified date September 2023
Source Nationwide Children's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 250
Est. completion date August 1, 2024
Est. primary completion date August 1, 2022
Accepts healthy volunteers No
Gender All
Age group N/A to 21 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• LabraGuard
Protection of the lips and the oral commissure during transoral procedures

Locations
Country Name City State
United States Nationwide Children's Hospital Columbus Ohio

Sponsors (2)
Lead Sponsor Collaborator
Nationwide Children's Hospital Zotarix LLC

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Surgical Field Visibility Surgeons level of visibility of the oropharynx on a scale of 1 to 10 baseline
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