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CompletedNCT05719753PRO033CSPUpdated Feb 9, 2023

The Effectiveness of a Bacteriophobic Coating on Urinary Catheters

An interventional study of Camstent Coated Catheter and Standard Care in Urinary Tract Infections, sponsored by Camstent Ltd.. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-09.

Sponsored by Camstent Ltd. · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 2 years 3 months after the study started (first participant enrolled Sep 2020, registered Dec 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

To assess if a bacteriophobic coating prevents biofilm and host protein accumulation on urinary catheters and inflammatory protein release in urine following catheterization

Read the detailed description

The purpose of the study is to provide pilot information on the characteristics of the biofilm formed on the coated catheter compared to a standard catheter. The two objectives are;

  1. to evaluate the catheter's on-label performance in customary clinical use.
  2. to quantify biofilm formation on the catheter surface, and to compare it with biofilm formation on the hospitals current uncoated catheters.
02

Conditions studied

  • Urinary Tract Infections
03

In context

Urinary Tract Infections

779 studies on the registry are indexed under Urinary Tract Infections; 132 are open to participants now.

This study's enrollment of 50 is below the median of 130 across 544 interventional studies indexed under Urinary Tract Infections.

Browse Urinary Tract Infections studies →

Lead sponsor

Camstent Ltd. is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. All patients undergoing colorectal resection routinely requiring a urinary catheter as part of their standard post-operative care.
  2. Patients aged 18-85 years will be eligible for the study.
  3. Able to give informed consent.

Exclusion criteria

Exclusion Criteria:

  1. Patients that have or recently (within 3 weeks) had a urinary catheter, or those with signs of current urinary tract infection.
  2. Pregnant patients.
  3. Patients with a potentially immunocompromised condition (steroids, HIV)
  4. Patients who are unable to give informed consent
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Placebo comparator
    Standard of Care

    Bard Catheter

    Device: Standard Care

  • Experimental
    Camstent Coated Catheter

    The Camstent Coated Foley Catheter is an all-silicone two-way Foley-type urinary catheter, to which a proprietary polymeric coating has been applied.

    Device: Camstent Coated Catheter

Interventions

  • DeviceCamstent Coated Catheter

    The Camstent Coated Foley Catheter is an all-silicone two-way Foley-type urinary catheter, to which a proprietary polymeric coating has been applied.

  • DeviceStandard Care

    Bard Catheter

06

What researchers measure

Primary outcomes

  1. An analytic characterisation of catheters after routine patient use, will yield estimates of the difference in biofilm density between coated and non-coated catheters.

    An analytic characterisation of catheters after routine patient use, will yield estimates of the difference in biofilm density between coated and non-coated catheters.

    Time frame: 1 year

Secondary outcomes

  1. catheter blockage

    catheter blockage

    Time frame: 1 year

  2. catheter associated infection

    catheter associated infection

    Time frame: 1 year

  3. Ease of insertion and removal of the catheter since it creates a very smooth and slippery surface using the NHS staff standard clinical feedback form.

    Ease of insertion and removal of the catheter since it creates a very smooth and slippery surface using the NHS staff standard clinical feedback form.

    Time frame: 1 year

07

Study locations

1 site
  • University of Nottingham
    Nottingham, Nottinghamshire NG7 2UH, United Kingdom
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05719753
Lead sponsor
Camstent Ltd.
Responsible party
Sponsor
First posted
Feb 9, 2023
Start date
Sep 15, 2020
Primary completion
Sep 20, 2021
Completion
Dec 20, 2021
Last update
Feb 9, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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