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A Pilot Study To Assess The Impact Of A Camstent Coated Catheter On Clinical Bacteriuria (CAM-SPC-001)

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ClinicalTrials.gov Identifier: NCT04658719
Recruitment Status : Not yet recruiting
First Posted : December 8, 2020
Last Update Posted : December 11, 2020
Sponsor:
Information provided by (Responsible Party):
Camstent Ltd.

Brief Summary:

A Pilot Study To Assess The Impact Of A Camstent Coated Catheter On Clinical Bacteriuria when compared to an uncoated catheter.

Each participant will take part in the trial from the time the participant signs the informed consent form (ICF).

After the screening visit, the participants will be allocated to either a coated catheter or an uncoated catheter. Participants will be assigned to receive trial treatment until the catheter has been removed, investigator's decision to withdraw the subject, noncompliance with trial treatment or procedures, unacceptable adverse event, or participant withdraws consent.

During the trial urine samples will be taken form the catheter port, temperature will be taken, and participants and healthcare providers will be asked to complete questionnaires.


Condition or disease Intervention/treatment Phase
Bacteriuria Device: Camstent Coated Catheter Device: Standard Care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: 'A Pilot Study To Assess The Impact Of A Camstent Coated Catheter On Clinical Bacteriuria.'
Estimated Study Start Date : February 2021
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
Experimental: Camstent Coated Catheter
The patented 'M4D coating' is applied to inner and outer surfaces using a 'dip/dry' process before sterilisation, creating a safe, inert, and long-lasting finish. The coating reduces friction of the catheter surface, enhancing patient comfort on insertion and withdrawal. It also incorporates the materials which virtually preclude biofilm formation. The coating doesn't elute antibacterial agents or toxins, avoiding the build-up of dead bacteria on the device surface and retaining effectiveness throughout extended use (NB. Effectiveness is not lost because of leaching away of an active antimicrobial agent). Finally, the absence of anti-bacterial moieties means that the healthy microbial flora is not disturbed.
Device: Camstent Coated Catheter
The patented 'M4D coating' is applied to inner and outer surfaces using a 'dip/dry' process before sterilisation, creating a safe, inert, and long-lasting finish. The coating reduces friction of the catheter surface, enhancing patient comfort on insertion and withdrawal. It also incorporates the materials which virtually preclude biofilm formation. The coating doesn't elute antibacterial agents or toxins, avoiding the build-up of dead bacteria on the device surface and retaining effectiveness throughout extended use (NB. Effectiveness is not lost because of leaching away of an active antimicrobial agent). Finally, the absence of anti-bacterial moieties means that the healthy microbial flora is not disturbed.

Active Comparator: Standard Care
Foley catheter, uncoated
Device: Standard Care
Uncoated Foley Catheter




Primary Outcome Measures :
  1. The primary efficacy endpoint is a decrease in the number of days in which bacterial concentrations are greater than 105 CFU/mL in coated catheters, as compared to uncoated control catheters [ Time Frame: 1 Year ]

Secondary Outcome Measures :
  1. • Patient Reported Outcomes (PRO) [ Time Frame: 1 Year ]
  2. • Reduction in the number of cases experiencing Symptomatic Bacteriuria (CAUTI) coated catheters vs. uncoated controls [ Time Frame: 1 Year ]
  3. • Reduction in the number of cases receiving prophylactic or therapeutic Antibiotics during catheter use in coated catheters vs. uncoated controls [ Time Frame: 1 Year ]
  4. • Reduction of number of cases experiencing blockage in coated catheters vs. uncoated controls [ Time Frame: 1 Year ]
  5. • Reduction in Biofilm [ Time Frame: 1 Year ]
  6. • Reduction in site infection [ Time Frame: 1 Year ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Require insertion or exchange of a urinary catheter in a suprapubic position as a component of their routine clinical care as per guidelines
  • Patients aged 18+ years will be eligible for the study.
  • Patient understands and is willing to participate in the study and is able to comply with study procedures and visits.

Exclusion Criteria:

  • Patients that have or recently (within 3 weeks) had a urinary catheter and displays symptoms of current urinary tract infection.2. Patients that have asymptomatic infection (if required may need a blood test to confirm)
  • Pregnant or Breastfeeding.
  • Patients with a potentially immunocompromised conditions (HIV)
  • Has a known silicone allergy or sensitivity
  • Use of investigational drug or device within four weeks prior to study entry that may interfere with this study.
  • Any medication deemed by the Investigator to potentially interfere with the study treatment
  • Participation in any other clinical study.
  • Has a known bloodstream infection or an infection that requires prolonged antibiotic therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04658719


Contacts
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Contact: Prital Patel, MSc +44 (0)333 987 4050 prital.patel@camstent.com

Sponsors and Collaborators
Camstent Ltd.
Additional Information:
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Responsible Party: Camstent Ltd.
ClinicalTrials.gov Identifier: NCT04658719    
Other Study ID Numbers: CAM-SPC-001
First Posted: December 8, 2020    Key Record Dates
Last Update Posted: December 11, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Bacteriuria
Urinary Tract Infections
Infections
Urologic Diseases