Ignite Creation Date:
2024-05-05 @ 11:04 PM
Last Modification Date:
2024-10-26 @ 10:27 AM
Study NCT ID:
NCT01243125
Status:
COMPLETED
Last Update Posted:
2014-08-07
First Post:
2010-11-15
Brief Title:
Study to Evaluate NVC-422 for Urinary Catheter Blockage and Encrustation
Sponsor:
NovaBay Pharmaceuticals Inc
Organization:
NovaBay Pharmaceuticals Inc
Study Overview
Official Title:
A Multicenter Double-blind Crossover Design Pilot Study to Evaluate the Effect of NVC-422 Catheter Irrigation on Urinary Catheter Patency
Status:
COMPLETED
Status Verified Date:
2014-08
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:
NVC-422 is a topical non-antibiotic fast-acting broad-spectrum anti-microbial which exhibits the potential to prevent the growth of urinary pathogens including Proteus and others
The use of a catheter irrigation solution that can prevent biofilm formation and encrustation leading to blockage may keep the catheter patent longer resulting in fewer catheter changes potentially lower incidence of UTIs and better patient quality of life
The study population will include male and female spinal cord injury SCI and other neurogenic bladder patients with chronic indwelling transurethral urinary catheters who have a recent repeated history of urinary catheter encrustation andor blockage
Subjects will receive two treatment regimens one treatment regimen with NVC-422 sterile irrigation solution and one treatment regimen with sterile saline irrigation solution Each treatment regimen will consist of a total of 8 treatments with a washout period between treatment regimens
The use of a catheter irrigation solution that can prevent biofilm formation and encrustation leading to blockage may keep the catheter patent longer resulting in fewer catheter changes potentially lower incidence of UTIs and better patient quality of life
The study population will include male and female spinal cord injury SCI and other neurogenic bladder patients with chronic indwelling transurethral urinary catheters who have a recent repeated history of urinary catheter encrustation andor blockage
Subjects will receive two treatment regimens one treatment regimen with NVC-422 sterile irrigation solution and one treatment regimen with sterile saline irrigation solution Each treatment regimen will consist of a total of 8 treatments with a washout period between treatment regimens
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