UrologicalPhase 2/3ACS1NCT01960517
Feasibility Assessment of ACS Catheter
A Phase 2/3 study testing ACS Catheter in people with Urological, run by Alternative Urological Catheter Systems Ltd. at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urological
- What is being tested?
- ACS Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2014to May 2014
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, at least 18 years of age.
- Patient or authorised representative must be able to comprehend and sign the Informed Consent Form prior to enrolment in the study.
- 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.
- Fitted with a suprapubic catheter (at least 2 weeks post insertion).
- Ability to attend out-patient clinic at regular intervals throughout the study and able to participate for a maximum of 8 weeks.
- History of catheter blockages, bypassing or episodes of pyrexia and bacteraemia in the last 2 months.
Who cannot join
- <18 years of age.
- Pregnant or lactating females.
- History of catheter associated septicaemia in the past month.
- Evidence of current systemic infection.
- Bladder pathology such as a tumour or stone >0.5cm as determined by cystoscopy.
- Flaccid bladder.
Show all 9Show fewer
- BMI>35.
- Current participation in another device or drug study.
- Unwilling or unable to provide informed consent.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Rotherham NHS Foundation Trust, Rotherham General Hospital
Rotherham, S60 2UD
About this study
Official title: A Feasibility Assessment of a New Urinary Catheter: The Alternative Catheter System ACS)
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.
- Conditions
- Urological
- Being tested
- ACS Catheter
- Keywords
- Urinary, Incontinence, Catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACS CatheterDevice
| Study group | Role | What they receive |
|---|---|---|
| Catheter placed | Experimental | Not described Receives: Device: ACS Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention of the ACS catheter
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2013 (estimated)
- Study startJan 2014
- Primary completionMar 2014 (estimated)
- Study completionMay 2014 (estimated)
Why it stopped: Sponsor decision not to proceed with study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alternative Urological Catheter Systems Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mr Isa Idhem, Principal investigator, Rotherham NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01960517
- Sponsor's protocol ID
- AUCS/2013/ACS01
- Acronym
- ACS1
- Status last verified
- Oct 2013
- First submitted
- 7 Oct 2013
- Last updated
- 26 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Assessment of a New Urinary Catheter: The Alternative Catheter System ACS)
- ClinicalTrials.gov ID
- NCT01960517
- Acronym / sponsor ID
- ACS1 / AUCS/2013/ACS01
- Conditions
- Urological
- Keywords
- Urinary, Incontinence, Catheter
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor decision not to proceed with study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Alternative Urological Catheter Systems Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Mar 2014 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 10 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Catheter placed | Experimental | Device: ACS Catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female, at least 18 years of age.
- Patient or authorised representative must be able to comprehend and sign the Informed Consent Form prior to enrolment in the study.
- 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.
- Fitted with a suprapubic catheter (at least 2 weeks post insertion).
- Ability to attend out-patient clinic at regular intervals throughout the study and able to participate for a maximum of 8 weeks.
Key exclusion criteria (9 listed)
- <18 years of age.
- Pregnant or lactating females.
- History of catheter associated septicaemia in the past month.
- Evidence of current systemic infection.
- Bladder pathology such as a tumour or stone >0.5cm as determined by cystoscopy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACS Catheter | Device | Catheter placed |
Primary outcome
Retention of the ACS catheter
Time frame: 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mr Isa Idhem principal investigator
Rotherham NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing ACS Catheter in people with Urological, run by Alternative Urological Catheter Systems Ltd. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention of the ACS catheter (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2015.