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Oral Device Clinical Trial

Primary Purpose

Tonsil Disease, Dental Diseases, Adenoid; Disorder (and Tonsils)

Status
Enrolling by invitation
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
LabraGuard
Sponsored by
Nationwide Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Tonsil Disease

Eligibility Criteria

undefined - 21 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Nationwide Children's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Oral Safety Device

Arm Description

patients on which the device "LabraGuard" is used.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 25, 2021
Last Updated
September 11, 2023
Sponsor
Nationwide Children's Hospital
Collaborators
Zotarix LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05022368
Brief Title
Oral Device Clinical Trial
Official Title
Surgical Safety Device Use During Transoral Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
May 24, 2021 (Actual)
Primary Completion Date
August 1, 2022 (Actual)
Study Completion Date
August 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nationwide Children's Hospital
Collaborators
Zotarix LLC

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tonsil Disease, Dental Diseases, Adenoid; Disorder (and Tonsils)

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Oral Safety Device
Arm Type
Experimental
Arm Description
patients on which the device "LabraGuard" is used.
Intervention Type
Device
Intervention Name(s)
LabraGuard
Intervention Description
Protection of the lips and the oral commissure during transoral procedures
Primary Outcome Measure Information:
Title
Surgical Field Visibility
Description
Surgeons level of visibility of the oropharynx on a scale of 1 to 10
Time Frame
baseline

10. Eligibility

Sex
All
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Oral Device Clinical Trial

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