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

NCT03790826 | Unknown FDA Device

• 1 other identifier: CIFCAT-001
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Bladder Infections and Inflammations

Keywords

bladder mucosal trauma

Outcome Measures

Primary Outcomes (1)

• Bladder mucosa damage assessment via computerized image analysis

  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.

  30 days

Secondary Outcomes (2)

• Bladder mucosa damage urologist visual assessment

  30 days

• Patient discomfort via Numeric Pain Rating Scale

  30 days

Study Arms (1)

Cystoscopic Inspection

EXPERIMENTAL

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

Device: cystoscopy

Interventions

cystoscopy DEVICE

Comparison of bladder mucosa via cystoscopy.

Cystoscopic Inspection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Inability to provide informed consent
• Unwilling or medically inappropriate for cystoscopy

Sponsors & Collaborators

• Nellie Medical, LLC: lead

MeSH Terms

Conditions

Cystitis; Inflammation

Interventions

Cystoscopy

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Urological; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Urologic Surgical Procedures; Urogenital Surgical Procedures

Central Study Contacts

James A Greenberg, MD

CONTACT

781-910-1968; JAGREENBERG@partners.org

Ronald Adams, MSME

CONTACT

5089445166; ron@cystosure.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2018
• First Posted: January 2, 2019
• Study Start: April 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: March 1, 2021
• Last Updated: March 26, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share