Feasibility of Structural and Functional Imaging of the Middle Ear and Its Constituents by Optical Coherence Tomography
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 主要终点
- Middle ear structures identified with the Aurisvue OCT device
研究概览
简要总结
Feasibility of structural and functional imaging of the middle ear and its constituents by optical coherence tomography.
详细描述
Rationale: Various middle ear diseases can affect anatomical structures of the middle ear in different ways. Unfortunately, current methods for assessing the structure and function of the constituents of the middle ear are limited and often fail to provide all clinically relevant data. Optical coherence tomography (OCT) is a technology that can provide valuable, additional information with a newly developed prototype OCT-device for structural and functional imaging of the middle ear.
Objective
To assess the feasibility and the clinical potential of structural and functional OCT imaging with a newly developed OCT-device in patients with various middle ear problems.
Study design: Observational study Study population: Adult patients presenting with various middle ear complaints at the Ear Nose Throat department of the Department of Otorhinolaryngology and Head and Neck Surgery, Erasmus Medical Center, Rotterdam, the Netherlands.
Main study parameters/endpoints: Percentage of patients in which structural OCT imaging was feasible (i.e., the OCT images showed a discernible tympanic membrane (TM) and at least one of the ossicles).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The burden is minimal: patient examination with Aurisvue is similar to the conventional examination with a standard otoscope and will take approximately 5 to 10 minutes. The risks are negligible: imaging is done with light levels well below the maximum permissible exposure level and sound levels to induce movement of the TM and the ossicular chain are well below the hazardous threshold.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18 or older
- •competent, willing and able to cooperate
排除标准
- •any acute or chronic condition that would limit the ability of the patient to participate in the study, per attending physician's indication
- •refusal to give informed consent
- •pregnancy or breastfeeding
研究组 & 干预措施
OCT imaging
OCT imaging
干预措施: Aurisvue (Device)
结局指标
主要结局
Middle ear structures identified with the Aurisvue OCT device
时间窗: 1 Year
Identification of each of the following anatomical middle ear structures with Aurisvue: tympanic membrane, malleus, incus, stapes and promontory (visible or not visible)
次要结局
- OCT-vibrometry measurements with the Aurisvue OCT device(1 Year)
研究者
Dr. R.M. Metselaar MD, PhD
Dr. R.M. Metselaar MD PhD
Erasmus Medical Center