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To Assess the Safety and Efficacy of the 4 Channel NMES Compensatory Medical Device in Swallowing, Multicenter Study

Dysphagia Clinical Trial

Official title:
A Prospective Study of Compensatory Medical Device Pivotal Clinical Study to Assess the Safety and Efficacy of the 4 Channel NMES, Multicenter Study

Clinical Trial Summary

This study is a confirmation study to prepare clinical trials to evaluate the safety and effectiveness of 4-channel electric stimulation therapy devices as a newly developed function for the treatment of dysphagia disorders. The purpose of this study is to validate the 4ch NMES device.

Clinical Trial Description

- Design: Prospective study

- Inclusion criteria of patient group: who has a dysphagia symptom and confirmed by video-fluoroscopic swallowing study

- Intervention: applied electrical stimulation by a "Synchronized Electrical Stimulation Device(SESD)"

- Main outcome measures: videofluoroscopic parameters, EQ-5D (EuroQoL-5D) questionnaire, II. M. D Anderson dysphagia inventory ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03670485
Study type Interventional
Source Seoul National University Hospital
Contact
Status Completed
Phase N/A
Start date June 1, 2019
Completion date February 21, 2020
View Details
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