Back to resultsOral 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
About this trial
This is an interventional prevention trial for Tonsil Disease
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
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
NCT ID
NCT05022368
First Posted
August 25, 2021
Last Updated
September 11, 2023
Sponsor
Nationwide Children's Hospital
Collaborators
Zotarix LLC
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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