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

NCT05483582 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2024-04-22

No results posted yet for this study

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.

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

Sponsors & Collaborators

  • Seoul National University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-01
Primary Completion
2024-12-31
Completion
2025-12-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05483582 on ClinicalTrials.gov