Feasibility Assessment of ACS Catheter (ACS1)

Alternative Urological Catheter Systems

Status and phase: Withdrawn; Phase 3; Phase 2

Conditions: Urological

Treatments: Device: ACS Catheter

Study type: Interventional

Funder types: Industry

Identifiers

NCT01960517

AUCS/2013/ACS01

Details and patient eligibility

About

This is a single centre, non-randomised, baseline controlled, prospective pilot clinical trial to be undertaken at Rotherham General Hospital, Rotherham, UK.

The study will examine the safety and performance of a new urinary catheter, the Alternative Catheter System (ACS) (Alternative Urological Catheter Systems Ltd (AUCS), Bristol, UK) which has been developed to reduce the morbidity of long-term catheterisation and the acknowledged deficiencies of the conventional Foley urinary catheter.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female, at least 18 years of age.
2. Patient or authorised representative must be able to comprehend and sign the Informed Consent Form prior to enrolment in the study.
3. Capable of using a catheter valve to empty the bladder and able to communicate their experience with the system OR who has a carer able to fulfil these tasks.
4. Fitted with a suprapubic catheter (at least 2 weeks post insertion).
5. Ability to attend out-patient clinic at regular intervals throughout the study and able to participate for a maximum of 8 weeks.
6. History of catheter blockages, bypassing or episodes of pyrexia and bacteraemia in the last 2 months.

Exclusion criteria

1. <18 years of age.
2. Pregnant or lactating females.
3. History of catheter associated septicaemia in the past month.
4. Evidence of current systemic infection.
5. Bladder pathology such as a tumour or stone >0.5cm as determined by cystoscopy.
6. Flaccid bladder.
7. BMI>35.
8. Current participation in another device or drug study.
9. Unwilling or unable to provide informed consent.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Catheter placed

Experimental group

Treatment:

Device: ACS Catheter