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RECRUITING
NCT05483582
NA

Clinical Trial for Clinical Excellence and Safety Evaluation of 4-channel Functional Electric Stimulator

Sponsor: Seoul National University Hospital

View on ClinicalTrials.gov

Summary

This study is a pilot 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 investigate the difference in effect by the electric stimulation method and to obtain the values such as mean, standard deviation and so on, and to determine the number of subjects to be studied for clinical trials of validation permission in the future.

Official title: Clinical Trial to Evaluate the Efficacy and Safety of a 4-channel Swallowing Function Electrical Stimulation Device Compared to a 2-channel Swallowing Function Electrical Stimulation Device for the Rehabilitation Mechanism

Key Details

Gender

All

Age Range

19 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

68

Start Date

2023-09-01

Completion Date

2025-12-31

Last Updated

2024-04-22

Healthy Volunteers

Yes

Conditions

Interventions

DEVICE

4-channel Electrical Stimulation Device

electrical stimulation at muscles which related with deglutition

DEVICE

2-channel Electrical Stimulation Device

electrical stimulation at muscles which related with deglutition

Locations (1)

Department of Rehabilitation Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine

Seongnam-si, Gyeonggi-do, South Korea