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

Laryngeal Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04575142
• Other study ID #: 20-01463
• Status: Recruiting
• Phase: N/A
• Start date: January 26, 2021
• Est. completion date: November 2024

Study information

• Verified date: November 2023
• Source: NYU Langone Health
• Contact: Efstratios Achlatis
• Phone: 646-754-1206
• Email: Achlae01[@]nyu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 88 Years

Eligibility

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

Related Conditions & MeSH terms

• Laryngeal Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	NYU Langone	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute change from baseline in mucosal wave grade	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.	Treatment Visit (Day 0), Follow up Visit (6-12 weeks)
Primary	Absolute and percentage change from baseline	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"	Treatment Visit (Day 0), Follow up Visit (6-12 weeks)
Primary	Change in Physician's satisfaction	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.	Treatment Visit (Day 0), Follow up Visit (6-12 weeks)
Primary	Change in Patient's discomfort	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.	Treatment Visit (Day 0), Follow up Visit (6-12 weeks)
Primary	Change in Lesion regression	Lesion regression (based on endoscopic measurement technique) Stills from the laryngoscopic exam will be imported and measured into the Image J software.	Treatment Visit (Day 0), Follow up Visit (6-12 weeks)