CatheterizationNCT00802750
Study Where Healthy Volunteers Evaluate LoFric Catheters
A study testing LoFric POBE in people with Catheterization, run by Wellspect HealthCare at 1 site in Sweden.
Trial summary
The purpose of this study is to evaluate healthy volunteers perception of catheterization with LoFric catheters with new solvents in the manufacturing process. The subjects will be catheterized three times during one visit day. 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
- Catheterization
- What is being tested?
- LoFric POBE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2008to Dec 2008
- Phase
- Interventional
- 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provision of written informed consent
- Healthy volunteers
- Males age 18 years and over
Who cannot join
- Known or suspected, current impairment of and/or decreased urethral sensibility
- History of urethral disease
- History of urinary tract infection within three months, or ongoing symptomatic urinary tract infection
- Use of medications that may affect the urethra's dryness (e. g. anti-cholinergic drugs or cortisone)
- Current drug, alcohol or other substance abuse
- Other significant disease or condition (e.g. benign prostate hypertrophy, other prostatic lesions), which may interfere with treatment and/or evaluation
- Allergy to Trimethoprim
- Suspected poor compliance with the protocol during the complete study period.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Clinical Research and Trial Centre, Lund University Hospital
Lund, SE-221 85
About this study
Official title: A Randomized, Single-blind, Cross-over, Single Centre Study in Healthy Volunteers Evaluating Subject Perception of Urinary Catheters Manufactured in a New Process With New Solvent
The purpose of this study is to evaluate healthy volunteers perception of catheterization with LoFric catheters with new solvents in the manufacturing process. The subjects will be catheterized three times during one visit day.
The hypothesis is that the subjects' perception of catheterization is the same when using the test catheters compared to the reference catheter.
- Conditions
- Catheterization
- Being tested
- LoFric POBE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LoFric POBEDevice
LoFric POBE, Nelaton 40 cm, CH 12 with new solvent. Each subject will use the reference catheter "LoFric POBE, Nelaton 40 cm, CH 12 with current solvent" before being catheterized with the test catheters.
LoFric POBEDevice
Unsalted LoFric POBE Hydro-Kit II, Nelaton 40 cm, CH 12 with new solvent Each subject will use the reference catheter "LoFric POBE, Nelaton 40 cm, CH 12 with current solvent" before being catheterized with the test catheters.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Device: LoFric POBE |
| B | Experimental | Not described Receives: Device: LoFric POBE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healthy volunteers perception of catheterization
Measured: At each catheterization (three times during one day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2008 (estimated)
- Study startNov 2008
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CatheterizationStudies 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wellspect HealthCare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ulf Malmqvist, MD, PhD, Assoc.Prof., Principal investigator, Clinical Research and Trial Centre, Lund University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00802750
- Sponsor's protocol ID
- YA-LSM-0001
- Status last verified
- Feb 2021
- First submitted
- 4 Dec 2008
- Last updated
- 5 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-blind, Cross-over, Single Centre Study in Healthy Volunteers Evaluating Subject Perception of Urinary Catheters Manufactured in a New Process With New Solvent
- ClinicalTrials.gov ID
- NCT00802750
- Acronym / sponsor ID
- YA-LSM-0001
- Conditions
- Catheterization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Wellspect HealthCareIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 5 Dec 2008 (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.
The purpose of this study is to evaluate healthy volunteers perception of catheterization with LoFric catheters with new solvents in the manufacturing process. The subjects will be catheterized three times during one visit day.
The hypothesis is that the subjects' perception of catheterization is the same when using the test catheters compared to the reference catheter.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Device: LoFric POBE |
| B | Experimental | Device: LoFric POBE |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Provision of written informed consent
- Healthy volunteers
- Males age 18 years and over
Key exclusion criteria (8 listed)
- Known or suspected, current impairment of and/or decreased urethral sensibility
- History of urethral disease
- History of urinary tract infection within three months, or ongoing symptomatic urinary tract infection
- Use of medications that may affect the urethra's dryness (e. g. anti-cholinergic drugs or cortisone)
- Current drug, alcohol or other substance abuse
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 |
|---|---|---|
| LoFric POBELoFric POBE, Nelaton 40 cm, CH 12 with new solvent. Each subject will use the reference catheter "LoFric POBE, Nelaton 40 cm, CH 12 with current solvent" before being catheterized with the test catheters. | Device | A |
| LoFric POBEUnsalted LoFric POBE Hydro-Kit II, Nelaton 40 cm, CH 12 with new solvent Each subject will use the reference catheter "LoFric POBE, Nelaton 40 cm, CH 12 with current solvent" before being catheterized with the test catheters. | Device | B |
Primary outcome
Healthy volunteers perception of catheterization
Time frame: At each catheterization (three times during one day)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2021.
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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.
Ulf Malmqvist, MD, PhD, Assoc.Prof. principal investigator
Clinical Research and Trial Centre, Lund University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LoFric POBE in people with Catheterization, run by Wellspect HealthCare at 1 site in Sweden.
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 3 inclusion and 8 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 Feb 2021. 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 Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Healthy volunteers perception of catheterization (time frame: At each catheterization (three times during one day)). 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 Feb 2021.