NCT03790826

Chronic Indwelling Foley and Catheter Associated Trauma (CIF-CAT) Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Nellie Medical, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

To determine whether an indwelling low profile Kohli Atraumatic Catheter causes less macro-morphologic inflammation and edema to the bladder mucosa than a traditional indwelling Foley catheter as assess by computerized image analysis.

Detailed description

The Kohli Atraumatic Catheter similarly aims to reduce bladder mucosal trauma with its low profile pancake shaped balloon versus the ovoid balloon of a traditional Foley catheter. The Kohli Atraumatic Catheter has a short, opened-ended tip that minimally protrudes through a patented low-profile donut-shaped balloon. The combination of the low profile and reduced tip length prevents the catheter from contacting the bladder walls and thereby minimize disruption of the bladder surface mucus layer and trauma to the urothelium - theoretically reducing the chance of bacterial invasion. A trial in which sheep were randomized to a traditional indwelling Foley catheter or a prototype Kohli Atraumatic Catheter demonstrated a dramatic reduction in both bladder wall trauma and edema. The ulcerated area dropped from 7.2% to 1.8% (75%) and the edema from 26.9% to 13.0% (52%). Statistical Analysis To compare the effects of 2 catheter types, data will be analyzed using the general linear models tools from SAS/STAT software and presented as means ± standard error of the mean. The model will include 2 catheter types, inflamed vs non-inflamed areas, and their interactions.

Conditions

• Bladder Infections and Inflammations

Interventions

Type	Name	Description
DEVICE	cystoscopy	Comparison of bladder mucosa via cystoscopy.

Timeline

• Start date: 2019-04-01
• Primary completion: 2019-12-01
• Completion: 2021-03-01
• First posted: 2019-01-02
• Last updated: 2019-03-26

Regulatory

• FDA-regulated device study