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LabraGuard Device for Oral Surgery

Phase 1

Waitlist Available

Research Sponsored by Nationwide Children's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Having a surgical procedure done through the mouth where the lips are at risk of injury

Subjects 21 years of age and under

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline

Awards & highlights

Study Summary

This trial is researching a new medical device designed to aid in retraction and protect lips during surgery in children. No personal info is collected except the surgery date.

Who is the study for?

This trial is for children and young adults up to 21 years old who are undergoing oral surgery that could potentially harm their lips. They must be treated by specific departments and give consent, or have a guardian do so. Those with silicone allergies or issues with the device fitting properly cannot participate.Check my eligibility

What is being tested?

The LabraGuard, a new soft silicone medical device designed to protect the lips during oral surgeries, is being tested for its effectiveness in different age groups of children.See study design

What are the potential side effects?

Since this trial involves a non-invasive protective device, there may not be direct side effects like those seen with medications; however, potential risks could include allergic reactions to silicone or discomfort from improper fit.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am having surgery through my mouth that might injure my lips.

Select...

I am 21 years old or younger.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Surgical Field Visibility

Trial Design

1Treatment groups

Experimental Treatment

Group I: Oral Safety DeviceExperimental Treatment1 Intervention

patients on which the device "LabraGuard" is used.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Nationwide Children's HospitalLead Sponsor

341 Previous Clinical Trials

5,220,253 Total Patients Enrolled

1 Trials studying Adenoidectomy

200 Patients Enrolled for Adenoidectomy

Zotarix LLCUNKNOWN

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor currently recruiting participants?

"Based on the clinicaltrials.gov page, this research protocol is not currently recruiting patients. The trial was initially listed on May 24th 2021 and last modified on September 11th 2023. Notwithstanding that, 18 other studies are actively searching for participants at present."

Answered by AI

Has the Oral Safety Device been granted authorization by the FDA?

"Our team at Power ranks the safety of Oral Safety Device a 1 due to it being in Phase 1, indicating there is limited data available for both its efficacy and security."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Oral Device Clinical Trial

Tendy Chiang 2021. "Oral Device Clinical Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05022368.