Oral Device Clinical Trial | NCT05022368

Studies
Oral Device Clinical Trial

NCT05022368

Sponsor

Nationwide Children's Hospital

Status

Unknown status

Last Update Posted

Sep 13, 2023Actual

Enrollment

250Estimated

Phase

Phase 1

Conditions

Tonsil Disease
Dental Diseases
Adenoid; Disorder (and Tonsils)

Interventions

LabraGuard

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 24, 2021Actual

Primary Completion Date

Aug 1, 2022Actual

Completion Date

Aug 1, 2024Estimated

First Submitted Date

Aug 25, 2021

First Submission Date that Met QC Criteria

Aug 25, 2021

First Posted Date

Aug 26, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 11, 2023

Last Update Posted Date

Sep 13, 2023Actual

Name	Class
Zotarix LLC	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

250Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Oral Safety Device	Experimental	patients on which the device "LabraGuard" is used.	Device: LabraGuard

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LabraGuard	Device	Protection of the lips and the oral commissure during transoral procedures	Oral Safety Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Surgical Field Visibility	Surgeons level of visibility of the oropharynx on a scale of 1 to 10	baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

21 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nationwide Children's Hospital		Columbus	Ohio	43205	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009057	Stomatognathic Diseases

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided