Feasibility Assessment of ACS Catheter

Urological Clinical Trial

— ACS1  

Official title:

A Feasibility Assessment of a New Urinary Catheter: The Alternative Catheter System ACS)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01960517
• Other study ID #: AUCS/2013/ACS01
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• First received: October 7, 2013
• Last updated: January 22, 2015
• Start date: January 2014
• Est. completion date: May 2014

Study information

• Verified date: October 2013
• Source: Alternative Urological Catheter Systems Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Urological

Intervention

Device:
• ACS Catheter

Locations

Country	Name	City	State
United Kingdom	Rotherham NHS Foundation Trust, Rotherham General Hospital	Rotherham

Sponsors (1)

Lead Sponsor	Collaborator
Alternative Urological Catheter Systems Ltd.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retention of the ACS catheter		12 weeks	No