Oral Device Clinical Trial

Sponsor

Nationwide Children's Hospital (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05022368

Collaborator

Zotarix LLC (Other)

250

Enrollment

Location

Arm

2.3

Anticipated Duration (Months)

110.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tonsil Disease Dental Diseases Adenoid; Disorder (and Tonsils)	Device: LabraGuard	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

250 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Surgical Safety Device Use During Transoral Surgery

Actual Study Start Date :

May 24, 2021

Anticipated Primary Completion Date :

Aug 1, 2021

Anticipated Study Completion Date :

Aug 1, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Surgical Field Visibility [baseline]
Surgeons level of visibility of the oropharynx on a scale of 1 to 10

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 21 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nationwide Children's Hospital	Columbus	Ohio	United States	43205

Sponsors and Collaborators

Nationwide Children's Hospital
Zotarix LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tendy Chiang, Assistant professor, Nationwide Children's Hospital

ClinicalTrials.gov Identifier:

NCT05022368

Other Study ID Numbers:

STUDY00000722

First Posted:

Aug 26, 2021

Last Update Posted:

Aug 26, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Stomatognathic Diseases

Study Results

No Results Posted as of Aug 26, 2021