Trials / Completed
CompletedNCT03670485
To Assess the Safety and Efficacy of the 4 Channel NMES Compensatory Medical Device in Swallowing, Multicenter Study
A Prospective Study of Compensatory Medical Device Pivotal Clinical Study to Assess the Safety and Efficacy of the 4 Channel NMES, Multicenter Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 51 (actual)
- Sponsor
- Seoul National University Hospital · Academic / Other
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Accepted
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.
Detailed 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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | 4 channel Electrical Stimulation Device | electrical stimulation at muscles which related with deglutition |
Timeline
- Start date
- 2019-06-01
- Primary completion
- 2020-02-21
- Completion
- 2020-02-21
- First posted
- 2018-09-13
- Last updated
- 2020-08-04
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT03670485. Inclusion in this directory is not an endorsement.