Clinical trial NCT04575142: Comparison of Office-based KTP and CO2 Laser Outcomes in Patients With Vocal Cord Lesions.
Official title: Comparison of Office-based KTP and CO2 Laser Outcomes in Patients With Vocal Cord Lesions.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laryngeal Diseases
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2020-10-05
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Absolute change from baseline in mucosal wave grade
timeFrame: Treatment Visit (Day 0), Follow up Visit (6-12 weeks)
measure: Absolute and percentage change from baseline
timeFrame: Treatment Visit (Day 0), Follow up Visit (6-12 weeks)
measure: Change in Physician's satisfaction
timeFrame: Treatment Visit (Day 0), Follow up Visit (6-12 weeks)
measure: Change in Patient's discomfort
timeFrame: Treatment Visit (Day 0), Follow up Visit (6-12 weeks)
measure: Change in Lesion regression
timeFrame: Treatment Visit (Day 0), Follow up Visit (6-12 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone
state: New York
Study officials:
affiliation: NYU Langone Health
name: Milan Amin, MD
role: PRINCIPAL_INVESTIGATOR
References: