Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06394115
Status:
COMPLETED
Last Update Posted:
2024-05-01
First Post:
2022-07-22
Brief Title:
Assessment of Novel Technology to Facilitate Drainage in Ostomy Pouches OUTFLOW Study
Sponsor:
ConvaTec Inc
Organization:
ConvaTec Inc
Study Overview
Official Title:
Assessment of Novel Technology to Facilitate Drainage in Ostomy Pouches OUTFLOW Study
Status:
COMPLETED
Status Verified Date:
2024-04
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:
OUTFLOW
Brief Summary:
The overall aim of this study is to determine the performance and safety of a novel coated material inside Convatec Ostomy Pouches and to explore the clinical and quality of life benefits that may occur with the use of the test product A minimum of 30 subjects and a maximum of 40 subjects will be recruited to obtain 30 complete datasets comprised of a minimum of 15 colostomy and minimum of 10 ileostomies
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None