Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06554015
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-02
Brief Title:
Prospective Longitudinal Study of Heylo for People Living With a Stoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Prospective Longitudinal Study of Heylo for People Living With a Stoma
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to longitudinally evaluate the usage and long-term benefits of the CE-marked device Heylo a digital leakage notification system for people with intestinal stomas The system which includes a smartphone application an adhesive sensor layer and a Bluetooth transmitter notifies users of changes in their baseplate status potentially reducing stoma effluent leakage and improving quality of life The physical Heylo device is part of the Coloplast Charter telehealth service
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?:
None