Renal CalculiPhase 2NCT00250406
Assessment of Drug-eluting Ureteral Stent on Bacterial Adherence and Biofilm Formation
A Phase 2 study testing Ureteral Stent in people with Renal Calculi and Ureteral Obstruction, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
The purpose of this study is to determine the clinical effects of a triclosan stent on adherent bacteria, stent biofilms, and patient urine cultures in patients with an indwelling triclosan ureteral stent. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Calculi, Ureteral Obstruction
- What is being tested?
- Ureteral Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2005to Mar 2009
- Phase
- Phase 2
- 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
- Patients who undergo ureteroscopy for any reason and require a ureteral stent post-operatively as determined by the surgeon (e.g. renal obstruction, ureteral edema, ureteral perforation, large stone fragments to pass, following ureteral dilation, ureteral trauma, solitary kidney, or any other reason left to the discretion of the surgeon).
- Patients undergoing extracorporeal shockwave lithotripsy (ESWL) who will require a stent as determined by the treating urologist (e.g. solitary kidney, ureteral stone > 1 cm, renal stone > 1.5 cm, significant renal obstruction, history of pyelonephritis, or any other reason left to the discretion of the surgeon).
- Patients who have or are going to have chronic ureteral stents, for any reason.
- Patients willing to return to St. Joseph's Hospital's Urology Clinic for follow-up.
Who cannot join
- Age ≤ 17 years
- Patients unable to consent.
- Any patient requiring endocarditis or prosthetic device prophylaxis (e.g. fresh arthroplasty etc.).
- Pregnant females
- Immunocompromised patients
- Significant urinary symptoms (urgency, dysuria, strangury, hematuria) or other bladder pathology that may cause these symptoms (e.g. interstitial cystitis)
- Anyone in the investigator's opinion that would be unsuitable.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Bacterial Adherence and Biofilm Formation on a Triclosan Loaded Ureteral Stent: A Phase II Study
The purpose of this study is to determine the clinical effects of a triclosan stent on adherent bacteria, stent biofilms, and patient urine cultures in patients with an indwelling triclosan ureteral stent. The patient populations that will be tested include: patients following ureteroscopy and patients scheduled to undergo shockwave lithotripsy who require a ureteral stent. It is hypothesized that triclosan eluting ureteral stents will reduce the number of bacteria both on (within biofilm) and around (in the urine) a ureteral stent.
- Conditions
- Renal Calculi, Ureteral Obstruction
- Being tested
- Ureteral Stent
- Keywords
- urolithiasis, ureteral stent, triclosan, drug eluting
- Medical subject headings
- Kidney Calculi, Ureteral Obstruction, Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ureteral StentDevice
Also called TRIUMPH STENT
triclosan-eluting ureteral stent
Ureteral StentDevice
Also called Percuflex Plus Stent
Percuflex Plus Stent as the control
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Percuflex Plus Ureteral Stent Receives: Device: Ureteral Stent |
| 2 | Experimental | TRIUMPH stent (triclosan-eluting stent) Receives: Device: Ureteral Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary objective is to determine if the number of stent adherent bacteria will be less in patients who receive a triclosan stent compared to a control/standard stent.
Measured: at time of intervention
Secondary outcomes (1)
Secondary objectives to be assessed include the amount of biofilm adherent to each stent and each patient's urine culture.
Measured: at time of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2005 (estimated)
- Study startNov 2005
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal CalculiStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Principal investigator, John Denstedt, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- John D Denstedt, MD, FRCSC, Principal investigator, St. Joseph's Hospital, The University of Western Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00250406
- Sponsor's protocol ID
- R-05-646
- Status last verified
- Dec 2013
- First submitted
- 4 Nov 2005
- Last updated
- 20 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Bacterial Adherence and Biofilm Formation on a Triclosan Loaded Ureteral Stent: A Phase II Study
- ClinicalTrials.gov ID
- NCT00250406
- Acronym / sponsor ID
- R-05-646
- Conditions
- Renal Calculi, Ureteral Obstruction
- Keywords
- urolithiasis, ureteral stent, triclosan, drug eluting
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- Nov 2005
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 8 Nov 2005 (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 determine the clinical effects of a triclosan stent on adherent bacteria, stent biofilms, and patient urine cultures in patients with an indwelling triclosan ureteral stent. The patient populations that will be tested include: patients following ureteroscopy and patients scheduled to undergo shockwave lithotripsy who require a ureteral stent. It is hypothesized that triclosan eluting ureteral stents will reduce the number of bacteria both on (within biofilm) and around (in the urine) a ureteral stent.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Ureteral StentPercuflex Plus Ureteral Stent |
| 2 | Experimental | Device: Ureteral StentTRIUMPH stent (triclosan-eluting stent) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who undergo ureteroscopy for any reason and require a ureteral stent post-operatively as determined by the surgeon (e.g. renal obstruction, ureteral edema, ureteral perforation, large stone fragments to pass, following ureteral dilation, ureteral trauma, solitary kidney, or any other reason left to the discretion of the surgeon).
- Patients undergoing extracorporeal shockwave lithotripsy (ESWL) who will require a stent as determined by the treating urologist (e.g. solitary kidney, ureteral stone > 1 cm, renal stone > 1.5 cm, significant renal obstruction, history of pyelonephritis, or any other reason left to the discretion of the surgeon).
- Patients who have or are going to have chronic ureteral stents, for any reason.
- Patients willing to return to St. Joseph's Hospital's Urology Clinic for follow-up.
Key exclusion criteria (7 listed)
- Age ≤ 17 years
- Patients unable to consent.
- Any patient requiring endocarditis or prosthetic device prophylaxis (e.g. fresh arthroplasty etc.).
- Pregnant females
- Immunocompromised patients
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 |
|---|---|---|
| Ureteral StentAlso: TRIUMPH STENTtriclosan-eluting ureteral stent | Device | 2 |
| Ureteral StentAlso: Percuflex Plus StentPercuflex Plus Stent as the control | Device | 1 |
Primary outcome
Primary objective is to determine if the number of stent adherent bacteria will be less in patients who receive a triclosan stent compared to a control/standard stent.
Time frame: at time of intervention
1 secondary outcome
Secondary objectives to be assessed include the amount of biofilm adherent to each stent and each patient's urine culture.
Time frame: at time of intervention
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 20 Dec 2013.
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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.
John D Denstedt, MD, FRCSC principal investigator
St. Joseph's Hospital, The University of Western Ontario
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ureteral Stent in people with Renal Calculi and Ureteral Obstruction, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's 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 7 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 20 Dec 2013. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 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?
Primary objective is to determine if the number of stent adherent bacteria will be less in patients who receive a triclosan stent compared to a control/standard stent. (time frame: at time of intervention). 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 20 Dec 2013.