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

Sponsor

Nellie Medical, LLC (Industry)

Overall Status

Unknown status

CT.gov ID

NCT03790826

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Bladder Infections and Inflammations	Device: cystoscopy	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

25 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2019

Anticipated Primary Completion Date :

Dec 1, 2019

Anticipated Study Completion Date :

Mar 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cystoscopic Inspection Comparison of bladder damage with traditional Foley catheter and the Kohli Atraumatic catheter. Interventions: cystoscopy	Device: cystoscopy Comparison of bladder mucosa via cystoscopy.

Arm

Intervention/Treatment

Experimental: Cystoscopic Inspection

Comparison of bladder damage with traditional Foley catheter and the Kohli Atraumatic catheter. Interventions: cystoscopy

Device: cystoscopy

Comparison of bladder mucosa via cystoscopy.

Outcome Measures

Primary Outcome Measures

Bladder mucosa damage assessment via computerized image analysis [30 days]
Macro-morphologic inflammation and edema assessment of bladder mucosa using computerized image analysis. Image Analysis Technique Image of each bladder will be analyzed using FLIR Research IR Software (FLIR Systems Inc., Wilsonville, OR) to determine the proportion of inflamed areas characterized by red surface including hemorrhage and ulceration, and edema (eg, swollen smooth surface) out of total bladder area.

Secondary Outcome Measures

Bladder mucosa damage urologist visual assessment [30 days]
Visual macro-morphologic inflammation and edema assessment of bladder mucosa by experienced urologists familiar with the assessment of bladder diseases. Images and videos from a first visit where the traditional Foley catheter has been in place will be compared to those from a subsequent cystoscopy. Urologists will be blinded as to the catheter associated with each block of images captured during the cystoscopy.
Patient discomfort via Numeric Pain Rating Scale [30 days]
A numeric pain rating scale chart will be completed by each patient for comparison of patient discomfort with a traditional indwelling Foley catheter in patients with chronic indwelling Foley catheters. The scale runs from 0 "No Pain" to 5 "Moderate Pain" and 10 "Worst Possible Pain." More information on the scale can be seen here "https://www.physio-pedia.com/Numeric_Pain_Rating_Scale" There are no Subscales and the marked score for first assessment will be compared to 2nd assessment to assess any changes in patient comfort with the two different catheters.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Men or Women older than age 18
Indwelling Foley urinary catheter for at least 30 days prior to entry with anticipation for continued indwelling urinary catheterization for at least 30 days after entry into the study.

Exclusion Criteria:

Inability to provide informed consent
Unwilling or medically inappropriate for cystoscopy

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Nellie Medical, LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nellie Medical, LLC

ClinicalTrials.gov Identifier:

NCT03790826

Other Study ID Numbers:

CIFCAT-001

First Posted:

Jan 2, 2019

Last Update Posted:

Mar 26, 2019

Last Verified:

Mar 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Keywords provided by Nellie Medical, LLC

bladder mucosal trauma

Additional relevant MeSH terms:

Cystitis

Inflammation

Study Results

No Results Posted as of Mar 26, 2019