Comparison of Office-based KTP and CO2 Laser Outcomes in Patients With Vocal Cord Lesions.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Absolute change from baseline in mucosal wave grade
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 88 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of laryngeal papillomatosis, hemorrhagic polyps, or leukoplakia/dysplasia of the vocal folds requiring in-office treatment.
- •Has the capacity to provide consent
排除标准
- •Accutane (Isotretinoin) within the past 6-12 months
- •History of keloid formation
- •Demonstration of excessive or unusually prolonged erythema
结局指标
主要结局
Absolute change from baseline in mucosal wave grade
时间窗: 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.
Change in Patient's discomfort
时间窗: 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.
Absolute and percentage change from baseline
时间窗: 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"
Change in Lesion regression
时间窗: 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.
Change in Physician's satisfaction
时间窗: 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.
次要结局
未报告次要终点