Bladder Infections and InflammationsNCT03790826
Chronic Indwelling Foley and Catheter Associated Trauma (CIF-CAT) Study
A study testing cystoscopy in people with Bladder Infections and Inflammations, run by Nellie Medical, LLC.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bladder Infections and Inflammations
- What is being tested?
- cystoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Apr 2019to Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Inability to provide informed consent
- Unwilling or medically inappropriate for cystoscopy
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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
- Being tested
- cystoscopy
- Keywords
- bladder mucosal trauma
- Medical subject headings
- Cystitis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cystoscopyDevice
Comparison of bladder mucosa via cystoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Cystoscopic Inspection | Experimental | Comparison of bladder damage with traditional Foley catheter and the Kohli Atraumatic catheter.
Interventions: cystoscopy Receives: Device: cystoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (2)
Bladder mucosa damage urologist visual assessment
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.
Measured: 30 days
Patient discomfort via Numeric Pain Rating Scale
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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2019
- Study startApr 2019 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder Infections and InflammationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nellie Medical, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03790826
- Sponsor's protocol ID
- CIFCAT-001
- Status last verified
- Mar 2019
- First submitted
- 27 Dec 2018
- Last updated
- 26 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Indwelling Foley and Catheter Associated Trauma (CIF-CAT) Study
- ClinicalTrials.gov ID
- NCT03790826
- Acronym / sponsor ID
- CIFCAT-001
- Conditions
- Bladder Infections and Inflammations
- Keywords
- bladder mucosal trauma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Nellie Medical, LLCIndustry (pharma, biotech, devices)
- Study start
- Apr 2019 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 2 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cystoscopic Inspection | Experimental | Device: cystoscopyComparison of bladder damage with traditional Foley catheter and the Kohli Atraumatic catheter. Interventions: cystoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Inability to provide informed consent
- Unwilling or medically inappropriate for cystoscopy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cystoscopyComparison of bladder mucosa via cystoscopy. | Device | Cystoscopic Inspection |
Primary outcome
Bladder mucosa damage assessment via computerized image analysis
Time frame: 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.
2 secondary outcomes
Bladder mucosa damage urologist visual assessment
Time frame: 30 days
Patient discomfort via Numeric Pain Rating Scale
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing cystoscopy in people with Bladder Infections and Inflammations, run by Nellie Medical, LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact James A Greenberg, MD (781-910-1968, JAGREENBERG@partners.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bladder mucosa damage assessment via computerized image analysis (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2019.