Evaluation of an Investigational Laser Otoscope for Detection of Middle Ear Effusion in Pediatric Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Clinician diagnostic accuracy using laser otoscope to assess middle ear effusion presence
研究概览
简要总结
The goal of this cross-sectional diagnostic accuracy investigational study is to learn about the usefulness of laser otoscopy in screening for middle ear fluid. The main questions it aims to answer are:
-Accuracy and usability of doctors using laser otoscopes
Participants already having ear tubes placed will have an examination with a laser otoscope and white light otoscope in order to determine and compare the device's diagnostic assistance. Tympanostomy findings will be used as the ground truth.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 6 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled to undergo unilateral or bilateral myringotomy with ear tube placement
- •Between the ages of 6 months to 18 years at the time of consent
- •Able to provide assent as judged by the investigator or delegated personnel, and their parent(s) or legal guardian(s) has signed the current Institutional Review Board (IRB) approved informed consent form along with the HIPAA Authorization for the use and release of Private Health Information (PHI) or applicable privacy protection
排除标准
- •History of prior ear tube placement
- •Anatomical abnormalities of the tympanic membrane or ear canal
- •Presence of excessive cerumen that cannot be removed pre-exam and may interfere with study procedures
- •Any of the following deformities of the external ear and tympanic membrane: congenital canal stenosis or atresia, severe canal tortuosity or curvature which prevents visualizing the tympanic membrane fully with an otoscope, canal wall exostoses or osteomas, markedly thickened or opaque tympanic membranes such as caused by chronic myringitis, or scarring or fibrosis of the tympanic membrane, tympanosclerosis or other heavy calcification of the tympanic membrane, tympanic membrane perforations, and grafted tympanic membranes.
研究组 & 干预措施
Investigational cohort
Pediatric patients 6 months to 18 years who have been scheduled for tympanostomy and ear tube placement.
干预措施: Laser otoscope examination (Device)
结局指标
主要结局
Clinician diagnostic accuracy using laser otoscope to assess middle ear effusion presence
时间窗: From enrollment to data collection at tympanostomy typically at 2-3 weeks
The primary endpoint is the accuracy, PPV, and NPV of the MEEscope in detecting MEE validated by myringotomy findings. These values will be compared to the standard white-light otoscopy findings in the same patients to demonstrate the relative accuracy of the experimental illumination vs white light illumination in detection of MEE.
次要结局
未报告次要终点