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Completed

NCT Number: NCT04575142

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

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.

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Key information

Conditions

Laryngeal Diseases Otorhinolaryngologic Diseases Respiratory Tract Diseases

Age range

18 year–88 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone

New York, 10016, United States

About this study

A flexible laryngoscope is passed through the patient's nose. Energy from the laser is delivered through a fiber. This unique quality allows the physician to thread the fiber through an endoscope and deliver energy. KTP is uniquely effective because the laser uses green light, which has an affinity with blood vessels. This means that the energy from the laser is absorbed more easily by blood vessels than other tissue. Targeting the blood supply of a lesion causes the lesion to slough off, leaving the surrounding tissue undamaged. However, the properties of the KTP are not necessarily ideal, in that it penetrates deep into the vocal fold, risking scar formation. On the other hand, the 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. The purpose of the study is to evaluate the fiber-based version of the CO2 laser in the office setting.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Presence of laryngeal papillomatosis, hemorrhagic polyps, or leukoplakia/dysplasia of the vocal folds requiring in-office treatment.
  • Has the capacity to provide consent

Exclusion criteria

  • Accutane (Isotretinoin) within the past 6-12 months
  • History of keloid formation
  • Demonstration of excessive or unusually prolonged erythema

Treatment and study plan

CO2 laser

Device

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.

Other names: AcuPulse Duo

Primary outcomes

  1. Absolute change from baseline in mucosal wave grade

    Time frame: Treatment Visit (Day 0), Follow up Visit (6-12 weeks)

    Absolute change from baseline in mucosal wave grade using videostroboscopy on each treated vocal fold 2-3 months after the treatment for both groups. Videostroboscopy is a standard of care procedure for patients with voice problems and would be performed regardless of the subject's participation in the study.

  2. Absolute and percentage change from baseline

    Time frame: Treatment Visit (Day 0), Follow up Visit (6-12 weeks)

    Absolute and percentage change from baseline in the Voice Handicap Index (VHI) score 2-3 months after the treatment. Measured by Voice Handicap Index (VHI-10), a self reported questionnaire assessing the frequency of characteristics of their voice and the effects their voice has on their lives. 10 statements using a scale where 0 is "Never" and 4 is "Always"

  3. Change in Physician's satisfaction

    Time frame: Treatment Visit (Day 0), Follow up Visit (6-12 weeks)

    In using a self reported questionnaire to determine how easy it was to use the CO2 laser. Questions asked: Ease of use, completeness of treatment, bleeding issues, complications and case time from laser start to finish.

  4. Change in Patient's discomfort

    Time frame: Treatment Visit (Day 0), Follow up Visit (6-12 weeks)

    Patient comfort during the procedure will be measured by Patient Discomfort questionnaire. (All lesion types). The Patient-Comfort Scale is a 5 scale rating: 1- no, 2- minimal, 3-mild, 4-moderate, 5-severe.

  5. Change in Lesion regression

    Time frame: Treatment Visit (Day 0), Follow up Visit (6-12 weeks)

    Lesion regression (based on endoscopic measurement technique) Stills from the laryngoscopic exam will be imported and measured into the Image J software.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 5, 2020
Registry last updated
Jun 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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