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LET Gel after STAR Particle Application for Local Anesthesia

N/A

Waitlist Available

Led By Eric I Felner, MD, MS

Research Sponsored by Emory University

Eligibility Criteria Checklist

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

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and immediately after application

Awards & highlights

Study Summary

This trial tests if adding tiny ceramic spikes to numbing gel makes it work faster to numb a specific area. Participants will report how quickly the gel works.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 hour after application up to 1 week

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 hour after application up to 1 week

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 hour after application up to 1 week for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Application site pain assessment

Time to achieve local anesthesia

Secondary outcome measures

Assessment of adverse events (AEs)

Assessment of serious adverse events (SAEs)

Change in the transepidermal water loss (TEWL)

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: LET Gel after STAR Particle ApplicationExperimental Treatment2 Interventions

Children, adolescents, and young adults will receive local anesthesia via different methods: STAR particles prior to lidocaine compared to topical lidocaine without the use of the STAR particles device.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

LET Gel after STAR Particle Application (Right Arm)

2023

N/A

~30

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Who is running the clinical trial?

Emory UniversityLead Sponsor

1,636 Previous Clinical Trials

2,560,551 Total Patients Enrolled

Children's Healthcare of AtlantaOTHER

165 Previous Clinical Trials

105,108 Total Patients Enrolled

Eric I Felner, MD, MSPrincipal InvestigatorEmory University

Frequently Asked Questions

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

Are elderly individuals being considered for enrollment in this research study?

"This research programme has an age criterion of 10 years or older and 21 years old or younger."

Answered by AI

Is it permissible for me to register as a participant in this trial?

"Candidates between the ages of 10 and 21 are able to join this medical study, providing that they have previously received local anesthesia. A total of 25 participants need to be recruited for the trial."

Answered by AI

To what extent is the capacity for this research endeavor?

"Affirmative. According to clinicaltrials.gov, this trial is actively recruiting members since its initial publication on March 19th 2023 and the last update was September 10th of that same year. The research team requires 25 participants across a single site for their investigation."

Answered by AI

What are the key goals of this research endeavor?

"This research is focused on evaluating the primary outcome of application site pain assessment over a period from STAR particle application until anaesthesia is achieved, up to one hour. Secondary outcomes include recording and assessing acute skin reactions post-STAR particle applications; logging adverse events starting after lidocaine administration for the subsequent 30 days; and noting serious adverse events observed during that same time frame."

Answered by AI

Are there any spots remaining for this clinical experiment?

"Affirmative. There is information on clinicaltrials.gov that suggests this trial, which was initially posted on March 19th 2023, is actively searching for participants at present time. Approximately 25 patients from one centre need to be enrolled."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Lidocaine Administration Using STAR Particles

Eric Felner 2023. "Lidocaine Administration Using STAR Particles". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06034340.