Ignite Creation Date:
2025-12-18 @ 8:30 AM
Ignite Modification Date:
2025-12-23 @ 9:56 PM
Study NCT ID:
NCT05644912
Status:
None
Last Update Posted:
2024-04-24 00:00:00
First Post:
2022-11-18 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Exploratory Investigation on a Novel Catheter
Sponsor:
None
Organization:
Study Overview
Official Title:
Exploratory Investigation on a Novel Catheter
Status:
None
Status Verified Date:
2023-04
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:
None
Brief Summary:
An exploratory, pre-market, open, prospective, interventional, clinical investigation at a limited number of centers for proof of concept of a new catheter.
In this proof of concept investigation, subjects experienced in using transanal irrigation (TAI) with a balloon catheter will be using study catheters at two occasions to primarily study if the catheter will stay in place during the water instillation when performing TAI.
Each subject will be followed during approximately one week, depending on the usual time between their TAI.
In this proof of concept investigation, subjects experienced in using transanal irrigation (TAI) with a balloon catheter will be using study catheters at two occasions to primarily study if the catheter will stay in place during the water instillation when performing TAI.
Each subject will be followed during approximately one week, depending on the usual time between their TAI.
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?: