跳至主要内容
临床试验/CTRI/2019/11/021968
CTRI/2019/11/021968招募中3 期

Multi-centric clinical trials of SRAVAN Indian Cochlear Implant system indigenously developed by DRDO

SOCIETY FOR BIOMEDICAL TECHNOLOGY5 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年12月11日最近更新:

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)

研究者

发起方
SOCIETY FOR BIOMEDICAL TECHNOLOGY
申办方类型
Other [Registered Society]

研究点 (5)

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