Indian Journal of Physical Medicine and Rehabilitation

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VOLUME 27 , ISSUE 1 ( March, 2016 ) > List of Articles

RESEARCH ARTICLE

Conception, Development, and Clinical Trial Design of Point-of-care Technologies: A Case of Improved FES Device Development

Abhishek Biswas, C V Shendkar, Bikas K Arya, PK Lenka, Ratnesh Kumar, M Mahadevappa

Citation Information : Biswas A, Shendkar CV, Arya BK, Lenka P, Kumar R, Mahadevappa M. Conception, Development, and Clinical Trial Design of Point-of-care Technologies: A Case of Improved FES Device Development. Indian J Phy Med Rehab 2016; 27 (1):2-9.

DOI: 10.5005/ijopmr-27-1-2

Published Online: 00-03-2016

Copyright Statement:  Copyright © 2016; Jaypee Brothers Medical Publishers (P) Ltd.


Abstract

Objective

This article presents a case study on the development of an indigenous stimulator device, including the design of its clinical trials and the process of its clinical trial registration in the newly launched clinical trial registry- India (CTRI). The ethical and regulatory issues involved in medical device clinical trials in India are also discussed.

Design and Methods

The entire development and trial cycle of a new medical device from ideation to technology transfer is explained in this case of a newly developed indigenous FES device. The primary emphasis is on how to systematically analyse the global trial registry databases to adequately frame a medical device trial. With this case study, we present how to shortlist relevant trials; we then compare them and explain the valid methods for registering a trial protocol in the CTRI.

Conclusions

Our work can act as a model or guide for rehabilitation researchers in India, facilitating there work in the medical device design and trial protocol development. Though our trial has been designed for and registered in the Indian CTRI trial registry, our work can be equally useful for researchers abroad who desire to conduct their medical device trials in India.


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