Ignite Creation Date:
2025-12-18 @ 8:40 AM
Ignite Modification Date:
2025-12-23 @ 10:40 PM
Study NCT ID:
NCT03670485
Status:
None
Last Update Posted:
2020-08-04 00:00:00
First Post:
2018-09-12 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
To Assess the Safety and Efficacy of the 4 Channel NMES Compensatory Medical Device in Swallowing, Multicenter Study
Sponsor:
None
Organization:
Study Overview
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
Status:
None
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
* 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
* 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: