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CO2 Laser

CO2 Laser for Vocal Cord Lesions

N/A
Recruiting
Led By Milan Amin, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Presence of laryngeal papillomatosis, hemorrhagic polyps, or leukoplakia/dysplasia of the vocal folds requiring in-office treatment
Has the capacity to provide consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up treatment visit (day 0), follow up visit (6-12 weeks)
Awards & highlights

Study Summary

This trial is testing to see if a CO2 laser device is better than the most commonly used Aura KTP laser device for vocal lesions.

Who is the study for?
This trial is for individuals who can consent and have specific vocal cord issues like laryngeal papillomatosis, hemorrhagic polyps, or leukoplakia/dysplasia needing in-office treatment. It's not suitable for those with prolonged redness of the skin, a history of keloid scars, or recent Accutane use.Check my eligibility
What is being tested?
The study compares two lasers used to treat vocal cord lesions: the CO2 laser (AcuPulse Duo) and the commonly used Aura KTP laser. The goal is to see which device offers better results for treating these conditions.See study design
What are the potential side effects?
Potential side effects from using these lasers could include discomfort at the site of treatment, swelling, changes in voice quality temporarily after the procedure, and rare chances of scarring.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have growths or changes in my vocal cords that need treatment in a doctor's office.
Select...
I am able to understand and agree to the study's procedures.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~treatment visit (day 0), follow up visit (6-12 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and treatment visit (day 0), follow up visit (6-12 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Absolute and percentage change from baseline
Absolute change from baseline in mucosal wave grade
Change in Lesion regression
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: CO2 laser device groupExperimental Treatment1 Intervention
Participants who will be undergoing laser treatment for their vocal nodes with a specific laser device. AcuPulse Duo, a CO2 laser is absorbed by water found in soft tissues and is independent of tissue color. It is very precise and causes less damage of the deep tissues, which results in less swelling and faster recovery. The absence of a long healing process means that most patients can resume their normal activities even on the same day The CO2 laser is the preferred laser for use in the operating room.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CO2 laser
2016
Completed Phase 3
~150

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,367 Previous Clinical Trials
839,731 Total Patients Enrolled
Milan Amin, MDPrincipal InvestigatorNYU Langone Health
2 Previous Clinical Trials
50 Total Patients Enrolled

Frequently Asked Questions

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

Is it still possible to enroll in this research endeavor?

"The investigation, which was initially launched on January 26th 2021 and recently updated on June 29th 2022, is actively looking for participants. This information can be found on the clinicaltrials.gov website."

Answered by AI

What criteria must a person meet to qualify for participation in this trial?

"Candidates for this trial must be between 18 and 88 years of age with a diagnosis for laryngeal disorders. The study is currently accepting around 60 patients."

Answered by AI

Is eligibility for this research restricted to those aged 85 years or younger?

"As per the requirements for participation, individuals between 18 and 88 years old may join this clinical trial."

Answered by AI

What is the capacity of participants for this clinical evaluation?

"Affirmative. Records from clinicaltrials.gov demonstrate that this study, which was first published on January 26th 2021 is still recruiting participants. Around 60 individuals must be enlisted from 1 clinic for the trial to move forward."

Answered by AI
~7 spots leftby Apr 2025