Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2026-01-09 @ 12:30 PM
Study NCT ID:
NCT06547905
Status:
COMPLETED
Last Update Posted:
2025-03-13
First Post:
2024-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of an Ostomy Leakage Detection System
Sponsor:
Hollister Incorporated
Organization:
Study Overview
Official Title:
Evaluation of an Ostomy Leakage Detection System
Status:
COMPLETED
Status Verified Date:
2025-03
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:
This study will evaluate the safety and efficacy of an ostomy leakage detection system.
Detailed Description:
Individuals with an ostomy will be recruited to evaluate an ostomy leakage detection system. The ostomy leakage detection system is designed to detect leaks and notify users of the leaks. Participants will evaluate the safety and efficacy of the leakage detection system.
Study Oversight
Has Oversight DMC:
False
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?: