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

NYU Langone Health

Status: Completed

Conditions: Laryngeal Diseases

Treatments: Device: CO2 laser

Study type: Interventional

Funder types: Other

Identifiers

NCT04575142

20-01463

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 88 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

CO2 laser device group

Experimental group

Description:

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:

Device: CO2 laser