What side effects are associated with this type of intervention?

Common treatments for laryngitis include voice rest, hydration, and in some cases, medical interventions such as corticosteroids or laser therapy. For treatments similar to the AcuPulse Duo CO2 Laser, which involves tissue vaporization, side effects may include temporary hoarseness, throat pain, and swelling. There is also a risk of infection, bleeding, and in rare cases, scarring or changes in voice quality. Patients should discuss these potential side effects with their healthcare provider to make an informed decision.

What prior FDA approvals exist?

The FDA has approved various treatments for laryngitis, including pharmacological therapies and laser treatments. While specific FDA approvals for the AcuPulse Duo CO2 Laser for laryngitis are not detailed, similar laser treatments like the KTP laser have been used for vocal cord lesions and conditions such as Reinke's edema. These treatments focus on reducing inflammation and removing lesions to improve vocal function. Pharmacological treatments often include anti-inflammatory medications and voice rest to manage symptoms.

What other types of research exist?

A promising novel alternative to the AcuPulse Duo CO2 Laser for laryngitis patients is the Aura KTP laser. This laser is commonly used for vocal cord lesions and is being compared to the AcuPulse Duo CO2 laser to determine the best outcomes for such conditions.

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CO2 Laser

CO2 Laser for Vocal Cord Lesions

N/A

Waitlist Available

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

Be older than 18 years old

Must not have

Accutane (Isotretinoin) within the past 6-12 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up treatment visit (day 0), follow up visit (6-12 weeks)

Awards & highlights

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have not taken Accutane in the last 6-12 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ treatment visit (day 0), follow up visit (6-12 weeks)

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

~160

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for laryngitis include voice rest, hydration, humidification, and medications such as corticosteroids and antibiotics. Voice rest helps reduce strain on the vocal cords, allowing inflammation to subside. Hydration and humidification keep the vocal cords moist, which is essential for healing. Corticosteroids reduce inflammation and swelling of the vocal cords, while antibiotics are used if a bacterial infection is present. Laser treatments like the AcuPulse Duo CO2 Laser work by vaporizing abnormal tissue, which can help remove lesions and promote healing. These treatments are crucial for laryngitis patients as they address the underlying inflammation and infection, facilitating quicker recovery and preventing chronic issues.

Pre- and post-operative voice therapy (PaPOV): Development of an intervention for patients with benign vocal fold lesions.A summary of the Clinical Practice Guideline for the Diagnosis and Management of Voice Disorders, 2018 in Japan.Combination of voice therapy and antireflux therapy rapidly recovers voice-related symptoms in laryngopharyngeal reflux patients.

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Who is running the clinical trial?

NYU Langone HealthLead Sponsor

1,379 Previous Clinical Trials

848,108 Total Patients Enrolled

Milan Amin, MDPrincipal InvestigatorNYU Langone Health

2 Previous Clinical Trials

50 Total Patients Enrolled

~2 spots leftby Jul 2025

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