Multi-centric clinical trials of SRAVAN Indian Cochlear Implant system indigenously developed by DRDO
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 5
- 主要终点
- IMPROVEMENT IN HEARING
研究概览
简要总结
Sensory neural hearing loss is a major clinical problem encountered in pediatric and adult population. Cochlear implantation is now an established and well accepted mode of rehabilitation of profound deaf around the world. However due to high cost of implant many patients are unable to afford it. An indigenous affordable cochlear implant system has been developed under the aegis of society for biomedical technology to benefit the needy population. The device needs to be subjected to multi-centric human trials to evaluate safety and efficacy in subjects with profound sensoryneural hearing loss. The primary outcome in terms of improvement in hearing and speech development will be measured during the followup period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 1.00 Year(s) 至 80.00 Year(s)(—)
- 性别
- All
入选标准
- •INDIVIDUALS WITH PRE-LINGUAL OR POST-LINGUAL SEVERE TO PROFOUND SENSORI-NEURAL HEARING LOSS WITH NO BENEFIT FROM HEARING AIDS.
排除标准
- •DEAFNESS DUE TO LESIONS OF ACOUSTIC NERVE OR OF CENTRAL AUDITORY PATHWAY
- •ABSENCE OF COCHLEAR DEVELOPMENT OR ABNORMAL COCHLEAR ANATOMY 3.ABSENCE OF COCHLEAR NERVE ON MRI
- •TYMPANIC MEMBRANE PERFORATIONS AND ACTIVE MIDDLE EAR INFECTIONS
- •POST MENINGITIS COCHLEAR OSSIFICATION.
结局指标
主要结局
IMPROVEMENT IN HEARING
时间窗: 12 months
IMPROVEMENT IN SPEECH PERCEPTION
时间窗: 12 months
次要结局
- IMPROVED OVERALL COMMUNICATION ABILITY(IMPROVED CONFIDENCE AND SOCIAL INTERACTIONS)
