Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2025-12-25 @ 10:07 PM
Study NCT ID:
NCT03897959
Status:
UNKNOWN
Last Update Posted:
2019-04-01
First Post:
2019-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
COMPARISON OF KOHLI AND FOLEY CATHETERS IN SUPRAPUBIC CATHETER PATIENTS
Sponsor:
Nellie Medical, LLC
Organization:
Study Overview
Official Title:
FOLEY VERSUS KOHLI FOR SUPRAPUBIC CATHETER ASSOCIATED PROBLEMS STUDY
Status:
UNKNOWN
Status Verified Date:
2019-03
Last Known Status:
RECRUITING
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:
The purpose of this medical research study is to compare two different urinary drainage catheters to see which has fewer problems with blockages and pain. The study involves completing 16 weekly 3-question surveys either online or by phone. The new catheters are FDA-approved and will be provided for FREE. No medications will be given.
Detailed Description:
The purpose of this study is to see if a redesign of the catheter to remove the extended tip of the conventional urinary catheter will reduce problems with catheter blockage or catheter-associated discomfort. By eliminating the extended tip, the bladder wall will no longer be subject to the tip rubbing on the bladder wall. This could lead to fewer problems with blockages and less irritation and trauma to the bladder lining. A reduction in trauma to the bladder wall could reduce pain, bladder inflammation/irritation and the risk of urinary tract infections.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: