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Oral Device Clinical Trial

NCT05022368 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2023-09-13

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

LabraGuard

Protection of the lips and the oral commissure during transoral procedures

Sponsors & Collaborators

  • Zotarix LLC

    collaborator UNKNOWN

  • Nationwide Children's Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-24
Primary Completion
2022-08-01
Completion
2024-08-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05022368 on ClinicalTrials.gov