NCT05022368

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2021

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 24, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 26, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

1.2 years

First QC Date

August 25, 2021

Last Update Submit

September 11, 2023

Conditions

Tonsil DiseaseDental DiseasesAdenoid; Disorder (and Tonsils)

Outcome Measures

Primary Outcomes (1)

  • Surgical Field Visibility

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

    baseline

Study Arms (1)

Oral Safety Device

EXPERIMENTAL

patients on which the device "LabraGuard" is used.

Device: LabraGuard

Interventions

LabraGuardDEVICE

Protection of the lips and the oral commissure during transoral procedures

Oral Safety Device

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Allergy to silicone
  • Unable to achieve good fit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Conditions

Stomatognathic Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

August 25, 2021

First Posted

August 26, 2021

Study Start

May 24, 2021

Primary Completion

August 1, 2022

Study Completion

August 1, 2024

Last Updated

September 13, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)