HealthyTest catheterNCT00832078
Test Catheter Pilot Study in Healthy Volunteers
A study testing SpeediCath Compact Male and Speedicath in people with Healthy, run by Coloplast A/S at 1 site in Denmark.
Trial summary
The purpose of this study is to evaluate the safety of an intermittent catheter in comparison with an already existing catheter on the market. The study is a randomised, single blinded, cross-over study including 25 healthy males. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- SpeediCath Compact Male and Speedicath
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2009to Apr 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older
- Male
- Signed informed consent
- Negative urine multistix
Who cannot join
- Abnormalities, diseases or surgical procedures performed in the lower urinary tract
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the safety of an intermittent catheter in comparison with an already existing catheter on the market. The study is a randomised, single blinded, cross-over study including 25 healthy males.
- Conditions
- Healthy
- Being tested
- SpeediCath Compact Male, Speedicath
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpeediCath Compact MaleDevice
CH 12 hydrophilic coated intermitten compact catheter
SpeedicathDevice
CH 12 hydrophilic coated intermittent coated catheter
| Study group | Role | What they receive |
|---|---|---|
| Group A | Other | SCCM (SpeediCath Compact Male catheter) then SC (SpeediCath cathter) on test day 1. SC then SCCM on test day 2 Receives: Device: SpeediCath Compact Male; Device: Speedicath |
| Group B | Other | SC (SpeediCath cathter)then SCCM (SpeediCath Compact Male catheter) on test day 1. SCCM then SC on test day 2 Receives: Device: SpeediCath Compact Male; Device: Speedicath |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discomfort
Discomfort measured on a Visual Analog Scale (VAS) from 0 (no discomfort) to 10 (worst imaginable discomfort)
Measured: After each catheterisation
Secondary outcomes (3)
Handling
Measured: After each catheterisation
Preference
Measured: At study termination
Haematuria
Measured: After each catheterisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00832078
- Sponsor's protocol ID
- DK058CC
- Acronym
- Test catheter
- Status last verified
- Aug 2012
- First submitted
- 26 Jan 2009
- Last updated
- 5 Sep 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Test Catheter Pilot Study in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00832078
- Acronym / sponsor ID
- Test catheter / DK058CC
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 29 Jan 2009 (estimated)
- Results
- Posted 5 Sep 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety of an intermittent catheter in comparison with an already existing catheter on the market. The study is a randomised, single blinded, cross-over study including 25 healthy males.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Other | Device: SpeediCath Compact Male, Device: SpeedicathSCCM (SpeediCath Compact Male catheter) then SC (SpeediCath cathter) on test day 1. SC then SCCM on test day 2 |
| Group B | Other | Device: SpeediCath Compact Male, Device: SpeedicathSC (SpeediCath cathter)then SCCM (SpeediCath Compact Male catheter) on test day 1. SCCM then SC on test day 2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years or older
- Male
- Signed informed consent
- Negative urine multistix
Key exclusion criteria (1 listed)
- Abnormalities, diseases or surgical procedures performed in the lower urinary tract
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 |
|---|---|---|
| SpeediCath Compact MaleCH 12 hydrophilic coated intermitten compact catheter | Device | Group A, Group B |
| SpeedicathCH 12 hydrophilic coated intermittent coated catheter | Device | Group A, Group B |
Primary outcome
Discomfort
Time frame: After each catheterisation
Discomfort measured on a Visual Analog Scale (VAS) from 0 (no discomfort) to 10 (worst imaginable discomfort)
3 secondary outcomes
Handling
Time frame: After each catheterisation
Preference
Time frame: At study termination
Haematuria
Time frame: After each catheterisation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SpeediCath Compact Male and Speedicath in people with Healthy, run by Coloplast A/S at 1 site in Denmark.
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 4 inclusion and 1 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: finished, as of the sponsor's last update on 5 Sep 2012. 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 Denmark. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Sep 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Discomfort (time frame: After each catheterisation). 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 5 Sep 2012.