Urinary CatheterPhase 1NCT02669342
Sharklet Catheter Study
A Phase 1 study testing Radiance™ Clear Sharklet® Silicone Foley Catheter and Silicone Foley Catheter in people with Urinary Catheter and Urinary Tract Infections, run by University of British Columbia at 1 site in Canada.
Trial summary
The aim of this study is to determine if the Sharklet catheter, with its unique coating, reduces infections in participants, when compared to a standard catheter. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Urinary Catheter, Urinary Tract Infections
- What is being tested?
- Radiance™ Clear Sharklet® Silicone Foley Catheter and Silicone Foley Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2016to Feb 2019
- Phase
- Phase 1
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient requires a chronic indwelling Foley catheter for at least 14 days. Catheters will not remain indwelling greater than 30 days at a time
- Patient is more than 19 years of age
- Patient is able to give informed consent
- Patient is able to attend follow-up sessions
Who cannot join
- Patient is less than 19 years of age
- Patient is pregnant
- Patient with a known allergy to silicone
- Patient has urinary tract anatomic abnormality that would prevent placement of a standard Foley catheter
- Patient unable to accommodate the catheter
- Patient has an active urinary tract infection (UTI) or other diagnosed infection that is untreated. Once the infection has been treated, the patient is eligible for study.
Show all 13Show fewer
- Patient currently taking (or expected to take) more than a single dose of antibiotics for prevention of other infections during the catheter indwell period
- Patient has uncontrolled fecal incontinence (uncontrolled stool/poop passage)
- Patient is unable to feel and/or communicate their symptoms
- Informed consent is unable to be obtained
- Patient is unable or unwilling to comply with the study follow-up schedule
- Patient has a medical condition or disorder that would limit life expectancy to less than 30 days or that may cause non-compliance with the protocol or confound the data analysis
- Any other reason that if in the opinion of the investigator would make the patient unsuitable for enrollment in the study
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
The Stone Centre, VGH/UBC
Vancouver, British Columbia, V5Z 1M9
Olga Arsovska, 604-875-4111 ext. 62421, olga.arsovska@ubc.ca
Dirk Lange, PhD
About this study
Official title: Randomized Controlled Trial for the Early Clinical Experience and Evaluation of the Radiance Clear Sharklet Silicone Foley Catheter
The aim of this study is to determine if the Sharklet catheter, with its unique coating, reduces infections in participants, when compared to a standard catheter.
Read the detailed description
The aim of this study is to determine if the Sharklet catheter, with its unique coating, reduces infections in participants, when compared to a standard catheter.
- Conditions
- Urinary Catheter, Urinary Tract Infections
- Being tested
- Radiance™ Clear Sharklet® Silicone Foley Catheter, Silicone Foley Catheter
- Keywords
- Infection, Urinary Catheter, Sharklet
- Medical subject headings
- Urinary Tract Infections, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiance™ Clear Sharklet® Silicone Foley CatheterDevice
Silicone Foley CatheterDevice
Also called Standard of care
| Study group | Role | What they receive |
|---|---|---|
| Group A: Sharklet Catheter for 2 weeks first | Active comparator | Arm A will have catheters inserted according to the schedule below:
1. Sharklet catheter inserted for 2 weeks
2. Standard catheter inserted for 2 weeks
3. Sharklet catheter inserted for 4 weeks
4. Standard catheter inserted for 4 weeks Receives: Device: Radiance™ Clear Sharklet® Silicone Foley Catheter; Device: Silicone Foley Catheter |
| Group B: Sharklet Catheter for 4 weeks first | Active comparator | Arm B will have catheters inserted according to the schedule below:
1. Sharklet catheter inserted for 4 weeks
2. Standard catheter inserted for 4 weeks
3. Sharklet catheter inserted for 2 weeks
4. Standard catheter inserted for 2 weeks Receives: Device: Radiance™ Clear Sharklet® Silicone Foley Catheter; Device: Silicone Foley Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Catheter scrapings examined for colonization/biofilm burden and compared to the urine screen collected from the participant (cfu/mL)
Determine if there will be less adherent bacteria/biofilm to the Sharklet catheter compared to the controls.
Measured: 12 weeks
Number of symptomatic Urinary tract infections (UTIs) determined by urine culture
Determine number of symptomatic UTIs between the 2 groups as determined by urine culture.
Measured: 12 weeks
Secondary outcomes (7)
Delay to symptomatic CA-SUTI
Delay to symptomatic catheter-associated symptomatic urinary tract infection (CA-SUTI)
Measured: 12 weeks
Incidence of bacteria
Incidence of bacteremia following CA-SUTI
Measured: 12 weeks
Incidence of Crustation
Incidence of catheter obstruction/encrustation requiring removal
Measured: 12 weeks
Incidence of Discomfort
Incidence of significant discomfort/pain requiring removal
Measured: 12 weeks
Surface analysis of the type of bacteria found on each catheter
Surface analysis (e.g., SEM) of removed catheters for qualitative assessment of bacterial colonization
Measured: 12 weeks
Surface analysis of the amount of encrustation
Surface analysis (e.g., SEM) of removed catheters for qualitative assessment of encrustation
Measured: 12 weeks
Surface analysis of the biofilm formation
Surface analysis (e.g., SEM) of removed catheters for qualitative assessment of biofilm formation
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 posted1 Feb 2016 (estimated)
- Study startAug 2016
- Primary completionFeb 2019 (estimated)
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary CatheterStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dirk Lange, University of British Columbia
- Investigators
- Dirk Lange, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02669342
- Sponsor's protocol ID
- H15-03435
- Status last verified
- Apr 2017
- First submitted
- 20 Jan 2016
- Last updated
- 6 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial for the Early Clinical Experience and Evaluation of the Radiance Clear Sharklet Silicone Foley Catheter
- ClinicalTrials.gov ID
- NCT02669342
- Acronym / sponsor ID
- H15-03435
- Conditions
- Urinary Catheter, Urinary Tract Infections
- Keywords
- Infection, Urinary Catheter, Sharklet
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Feb 2019 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 1 Feb 2016 (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 aim of this study is to determine if the Sharklet catheter, with its unique coating, reduces infections in participants, when compared to a standard catheter.
Detailed description
The aim of this study is to determine if the Sharklet catheter, with its unique coating, reduces infections in participants, when compared to a standard catheter.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Sharklet Catheter for 2 weeks first | Active comparator | Device: Radiance™ Clear Sharklet® Silicone Foley Catheter, Device: Silicone Foley CatheterArm A will have catheters inserted according to the schedule below: 1. Sharklet catheter inserted for 2 weeks 2. Standard catheter inserted for 2 weeks 3. Sharklet catheter inserted for 4 weeks 4. Standard catheter inserted for 4 weeks |
| Group B: Sharklet Catheter for 4 weeks first | Active comparator | Device: Radiance™ Clear Sharklet® Silicone Foley Catheter, Device: Silicone Foley CatheterArm B will have catheters inserted according to the schedule below: 1. Sharklet catheter inserted for 4 weeks 2. Standard catheter inserted for 4 weeks 3. Sharklet catheter inserted for 2 weeks 4. Standard catheter inserted for 2 weeks |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient requires a chronic indwelling Foley catheter for at least 14 days. Catheters will not remain indwelling greater than 30 days at a time
- Patient is more than 19 years of age
- Patient is able to give informed consent
- Patient is able to attend follow-up sessions
Key exclusion criteria (13 listed)
- Patient is less than 19 years of age
- Patient is pregnant
- Patient with a known allergy to silicone
- Patient has urinary tract anatomic abnormality that would prevent placement of a standard Foley catheter
- Patient unable to accommodate the catheter
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 |
|---|---|---|
| Radiance™ Clear Sharklet® Silicone Foley Catheter | Device | Group A: Sharklet Catheter for 2 weeks first, Group B: Sharklet Catheter for 4 weeks first |
| Silicone Foley CatheterAlso: Standard of care | Device | Group A: Sharklet Catheter for 2 weeks first, Group B: Sharklet Catheter for 4 weeks first |
Primary outcome
Catheter scrapings examined for colonization/biofilm burden and compared to the urine screen collected from the participant (cfu/mL)
Time frame: 12 weeks
Determine if there will be less adherent bacteria/biofilm to the Sharklet catheter compared to the controls.
Number of symptomatic Urinary tract infections (UTIs) determined by urine culture
Time frame: 12 weeks
Determine number of symptomatic UTIs between the 2 groups as determined by urine culture.
7 secondary outcomes
Delay to symptomatic CA-SUTI
Time frame: 12 weeks
Incidence of bacteria
Time frame: 12 weeks
Incidence of Crustation
Time frame: 12 weeks
Incidence of Discomfort
Time frame: 12 weeks
Surface analysis of the type of bacteria found on each catheter
Time frame: 12 weeks
Surface analysis of the amount of encrustation
Time frame: 12 weeks
Surface analysis of the biofilm formation
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2017.
- Individual participant dataSharing planned: No
Related trials for Urinary Catheter
Not yet recruitingObservational study
Novel Antimicrobial Solution to Prevent Infections
Kidney Stone, Infection
Not yet recruiting
Effect of Voiding Position (Standing in the Shower vs. Sitting) on Post- Void Residual Urine Volume (PVR) After Removal of Urinary Catheter in Women Following Vaginal Delivery With Epidural Analgesia: A Double- Blind Randomized Controlled Trial
Postpartum Urinary Retention
Active, not recruiting
The Effect of QR Code-Based Video Training on Knowledge Level, Self-Management, and Self-Efficacy in Patients With Urinary Catheters: A Randomized Controlled Study
Urinary Catheters, Nursing Care
Not yet recruitingObservational study
Evaluate of the Use of Uromune as a Potential Non-antibiotic Prophylactic Strategy for Catheter-associated Urinary Tract Infection in Patients With Long-term Catheterization.
Catheter-Associated Urinary Tract Infections (CAUTIs)
Not yet recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
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.
Dirk Lange, PhD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Radiance™ Clear Sharklet® Silicone Foley Catheter and Silicone Foley Catheter in people with Urinary Catheter and Urinary Tract Infections, run by University of British Columbia at 1 site in Canada.
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 13 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: status not confirmed, as of the sponsor's last update on 6 Apr 2017. 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 Canada. 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 phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Olga Arsovska (604-875-4111 ext. 62421, olga.arsovska@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Catheter scrapings examined for colonization/biofilm burden and compared to the urine screen collected from the participant (cfu/mL) (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 6 Apr 2017.