Evaluation of a New Biocompatible Pressure Equalizing Tube
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Pressure-equalizing tube with Duckbill Valve stop air and water passage during middle ear infection treatment
研究概览
简要总结
Otitis media is the most common illness in children and 5% to 10% of their symptom cause by fluids in their middle ear . The OME can cause hearing loss included poor development of speech and poor communication.
The surgical procedure is considered simple and relatively safe, but several complications may occur after Pressure Equalizing tube insertion. The most prevalent complications are otorrhea, biofilm and formation of retraction pockets. Otorrhea occurs in 30% to 83% of children with tube and is mainly due bacterial contamination of the middle ear either from external ear canal or impaired Eustachian tube. Swimming can facilitate the entry of bacteria into the middle ear from the ear canal through the PE tubes, and this assumption is reinforced by the statistically significant association between the rate of otorrhea and the non-utilization of ear plugs in children who swim (from 47% in children who used ear plugs to 56% in those who did not).
详细描述
The researcher at Beckman Laser Institute, University of California, Irvine, develops new medical tool device call biocompatible Pressure Equalizing tube which can stop air passage and pressure equalization instantly, and can prevents water into the middle ear cavity. evaluate and compare the efficacy of a biocompatible Pressure Equalizing tube that enables air passage and pressure equalization almost instantly, while prevents the entrance of fluids, specially water, into the middle ear cavity.
The biocompatible Pressure Equalizing tube can reduce the rate of postoperative otorrhea,air passage between outside and middle ear cavity,prevents formation of retraction pockets in TM and swimming with lower risk of otorrhea.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male/ female at all age- newborn to adult.
- •Non- pregnant woman.
- •Diagnose of middle ear infection and plan for surgery procedure
排除标准
- •Pregnant woman
- •Incompetent adults (i.e. individuals with cognitive impairment)
- •Presence of immunodeficiency; cystic fibrosis; sickle cell disease;
- •Another major systemic disease
- •Congenital malformation of the external, middle, or inner ear
- •Sensorineural hearing loss; otoneurologic disease
- •History of prior ear surgery such as tympanoplasty, tympanomastoidectomy, or mastoidectomy; cholesteatoma; chronic mastoiditis; intratemporal or intracranial suppurative complications of otitis media
- •Use of ototoxic medication (except topical use)
结局指标
主要结局
Pressure-equalizing tube with Duckbill Valve stop air and water passage during middle ear infection treatment
时间窗: up to 6 months
次要结局
未报告次要终点
研究者
Beckman Laser Institute and Medical Center
Hamid Djalilian, M.D.,Associate Professor of Clinical Otolaryngology
University of California, Irvine