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Comparison of Office-based KTP and CO2 Laser Outcomes in Patients With Vocal Cord Lesions.

NCT04575142 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-06-24

No results posted yet for this study

Summary

The purpose of this study is to test the outcomes of a CO2 laser device called AcuPulse Duo on vocal lesions and compare them to the most commonly used Aura KTP laser in order to determine which device has the best results. The CO2 laser device is an already FDA approved device. However, there have been no studies comparing the two devices for this use.

Conditions

  • Laryngeal Diseases

Interventions

DEVICE

CO2 laser

the CO2 laser (AcuPulse DUO, Lumenis, Yokneam, Israel) generally ranges from 3 to 10 W in superpulse mode, with 0.05 second on/0.01 second off, depending on lesion size and location of the lesion(s). The CO2 laser can be used in a continuous, pulsed, or superpulsed mode. The superpulsed mode reduces the exposure time to a few nanoseconds while delivering high energies of 400 to 500 W with each peak. The rest time between each peak allows the tissues to cool and reduces thermal injury to adjacent tissues.

Sponsors & Collaborators

Principal Investigators

  • Milan Amin, MD · NYU Langone Health

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
88 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-26
Primary Completion
2021-06-29
Completion
2021-06-29

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04575142 on ClinicalTrials.gov