Multi-center, Open-label, Non-randomized, Single-arm Clinical Study to Assess the Safety and Performance of Earol® in Adult Patients With Ear Wax
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 5
- 主要终点
- SAEs and AEs reported
研究概览
简要总结
Accumulation of ear wax in the external ear canal is a common pathology. The presence of ear wax not only interferes with the clinician's view of the tympanic membrane, but may also result in hearing loss and vertigo, and may predispose to ear infections.
Removal of ear wax is facilitated using a variety of cerumenolytics, or ear wax solvents. The current study is designed to evaluate the safety and the cerumenolytic effects of the Earol product, when dosed into the auditory canal prior to the dewaxing and ear cleaning procedure. This study is designed to be conducted in the primary care setting as a prospective clinical trial.
A detailed literature review has been conducted to provide a background summary of relevant information on the disease/pathology, other available treatment options and the pre-clinical testing and clinical research that has been conducted to date on the intended population or related populations and/or the device.
The aim for conducting this clinical investigation is to perform a PMCF to evaluate the safety and performance of Earol. Although there are alternative methods for ear wax removal, Earol represents a simple method based on natural ingredients (olive oil) which aids the removal of ear wax as well as prevents appearance of clinical symptoms in the ear canal (E.g. reducing itching and irritation).
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must be willing to provide written informed consent prior to any clinical investigation related procedure;
- •Male or female patients over 18-year-old;
- •Presence of ear wax in both ear canals with a minimum of > 50% ear wax blockage in at least one ear (level 4) and > 25% blockage in the contralateral ear (level 3) as assessed using the TMVSS;
- •Subject must be willing and able to perform all the visits, follow the PI instructions and complete the follow-up of the study.
排除标准
- •Subject is currently participating in another clinical investigation or has participated in another clinical investigation in the past 30 days prior to the start of the present study;
- •Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period;
- •Presence of other anatomic or comorbid conditions (e.g. ear eczema or seborrhea), or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness;
- •Presence or history of a tympanic membrane perforation or tympanostomy tubes at any time during the previous 6 months;
- •Presence or history of a known or suspected ear infection (i.e. otitis externa or otitis interna) in the previous 2 months;
- •Presence of a known or suspected chronic suppurative otitis media;
- •Presence or history of a known or suspected keratosis obturans;
- •Presence of known or suspected mastoiditis;
- •Use of any ototopical drug or OTC product or ear wax-removal product (except for water or physiologic saline) during the preceding 3 days;
- •Hypersensitivity to any product ingredient(s) or history of anaphylactic/anaphylactoid reactions;
- •Temporal bone neoplasm.
结局指标
主要结局
SAEs and AEs reported
时间窗: Day 6
Adverse Events (AEs) and Serious Adverse Events (SAEs) post-treatment
次要结局
- Ear clinical symptoms(Day 0 and Day 6)
- SAEs and AEs reported(Day 12)
- Cerumen blockage assesment(Day 0 and Day 6)
- Patient clinical symptoms(Day 0 and Day 6)
- Patient clinical symptom and ease-of-use(Day 6)