NCT04658719

A Pilot Study To Assess The Impact Of A Camstent Coated Catheter On Clinical Bacteriuria

'A Pilot Study To Assess The Impact Of A Camstent Coated Catheter On Clinical Bacteriuria.'

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Camstent Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bacteriuria

Interventions

Type	Name	Description
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.
DEVICE	Standard Care	Uncoated Foley Catheter

Timeline

• Start date: 2021-02-01
• Primary completion: 2021-09-01
• Completion: 2021-12-01
• First posted: 2020-12-08
• Last updated: 2020-12-11