To Assess the Safety and Efficacy of the 4 Channel NMES Compensatory Medical Device in Swallowing, Multicenter Study
NCT03670485 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51
Last updated 2020-08-04
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.
Conditions
Interventions
- DEVICE
-
4 channel Electrical Stimulation Device
electrical stimulation at muscles which related with deglutition
Sponsors & Collaborators
-
Seoul National University Hospital
lead OTHER
Principal Investigators
-
Jusuk Ryu, M.D. PhD · Seoul National University Bundang Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 19 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2019-06-01
- Primary Completion
- 2020-02-21
- Completion
- 2020-02-21
Countries
- South Korea
Study Locations
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