Urinary CalculiPhase 4NCT00199524
Use of a Ureteral Access Sheath During Ureteroscopy and Its Effect on Stone Free Rate
A Phase 4 study testing Navigator Ureteral Access Sheath in people with Urinary Calculi, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 5 sites in Canada.
Trial summary
Patients with upper ureteral or renal stones will be randomized to undergoing ureteroscopy with or without a ureteral access sheath. The sheath is designed to facilitate ureteroscope insertion and re-insertion, thus allowing fragments to be basketed out. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Calculi
- What is being tested?
- Navigator Ureteral Access Sheath
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 5 sitesCanada
- Study dates
- May 2005to May 2009
- Phase
- Phase 4
- 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
- Upper ureteral (proximal to iliac vessels/iliac crest) calculi;
- Renal calculi;
- Normal renal function;
- Any stone composition;
- Single or multiple stones(planned treatment of all stones at this surgery);
- Age > 18 years;
- Able and willing to return treatment centre for follow-up visits; AND
- Signed study consent
Who cannot join
- Ureteric calculi distal to the level of the iliac vessels/iliac crest;
- Failed ureteroscopy for same stone (i.e. has to be the first ureteroscopic procedure for this stone, however a prior failed extracorporeal shockwave lithotripsy (SWL) is acceptable);
- Bilateral ureteroscopy;
- If an adjunctive procedure is planned post ureteroscopy (e.g. percutaneous nephrolithotomy, SWL) (i.e. it is known preoperatively that a ureteroscopic procedure will not render the patient stone free and that ancillary procedures will be necessary);
- If in the investigators opinion, enrollment would be not be appropriate; OR
- Pregnancy
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
Edmonton Prostate and Urological Research Centre
Edmonton, Alberta, T5H 4B9
Centre for Advanced Urological Research at Queen's University
Kingston, Ontario, M5B 1W8
Urology at St. Joseph's Hospital, The University of Western Ontario
London, Ontario, N6A 4V2
Kidney Stone Program at St. Michael's Hospital
Toronto, Ontario, M5B 1W8
The Prostate Centre at Vancouver General Hospital
Vancouver, British Columbia, V5Z 3J5
About this study
Official title: A Prospective Randomized Controlled Clinical Trial of the Use of a Ureteral Access Sheath During Ureteroscopy and Its Effect on Stone Free Rate
Patients with upper ureteral or renal stones will be randomized to undergoing ureteroscopy with or without a ureteral access sheath. The sheath is designed to facilitate ureteroscope insertion and re-insertion, thus allowing fragments to be basketed out. Stone free rates at 3 months will be determined between the two groups.
The investigators hypothesize that the use of the ureteral access sheath with ureteroscopy will result in improved stone free rates at 3 months compared to ureteroscopy without use of a sheath.
- Conditions
- Urinary Calculi
- Being tested
- Navigator Ureteral Access Sheath
- Keywords
- ureteroscopy, stone free
- Medical subject headings
- Urinary Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Navigator Ureteral Access SheathDevice
Also called Navigator Ureteral Access Shealth
ureteral access sheath
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | ureteroscopy with ureteral access sheath Receives: Device: Navigator Ureteral Access Sheath |
| 2 | No intervention | ureteroscopy without ureteral access sheath |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary end point is the stone free rate at 3 months post ureteroscopy.
Measured: 3 months post ureteroscopy
Secondary outcomes (1)
Secondary end points include operative and surgical factors such as operative time, stone size, stone location, stone composition, patient sex and the presence of a ureteric stent post-op.
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 posted20 Sep 2005 (estimated)
- Study startMay 2005
- Primary completionMar 2009
- Study completionMay 2009
Why it stopped: Enrollment was slower than anticipated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 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
- Investigators
- Hassan Razvi, MD, FRCSC, Principal investigator, Urology, St. Joseph's Hospital, The University of Western Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00199524
- Sponsor's protocol ID
- R-05-002
- Status last verified
- Oct 2009
- First submitted
- 13 Sep 2005
- Last updated
- 14 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Clinical Trial of the Use of a Ureteral Access Sheath During Ureteroscopy and Its Effect on Stone Free Rate
- ClinicalTrials.gov ID
- NCT00199524
- Acronym / sponsor ID
- R-05-002
- Conditions
- Urinary Calculi
- Keywords
- ureteroscopy, stone free
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment was slower than anticipated.
- Enrolment
- 44 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
- May 2005
- Primary completion
- Mar 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 20 Sep 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.
Patients with upper ureteral or renal stones will be randomized to undergoing ureteroscopy with or without a ureteral access sheath. The sheath is designed to facilitate ureteroscope insertion and re-insertion, thus allowing fragments to be basketed out. Stone free rates at 3 months will be determined between the two groups.
The investigators hypothesize that the use of the ureteral access sheath with ureteroscopy will result in improved stone free rates at 3 months compared to ureteroscopy without use of a sheath.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Navigator Ureteral Access Sheathureteroscopy with ureteral access sheath |
| 2 | No intervention | –ureteroscopy without ureteral access sheath |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Upper ureteral (proximal to iliac vessels/iliac crest) calculi;
- Renal calculi;
- Normal renal function;
- Any stone composition;
- Single or multiple stones(planned treatment of all stones at this surgery);
Key exclusion criteria (6 listed)
- Ureteric calculi distal to the level of the iliac vessels/iliac crest;
- Failed ureteroscopy for same stone (i.e. has to be the first ureteroscopic procedure for this stone, however a prior failed extracorporeal shockwave lithotripsy (SWL) is acceptable);
- Bilateral ureteroscopy;
- If an adjunctive procedure is planned post ureteroscopy (e.g. percutaneous nephrolithotomy, SWL) (i.e. it is known preoperatively that a ureteroscopic procedure will not render the patient stone free and that ancillary procedures will be necessary);
- If in the investigators opinion, enrollment would be not be appropriate; OR
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 |
|---|---|---|
| Navigator Ureteral Access SheathAlso: Navigator Ureteral Access Shealthureteral access sheath | Device | 1 |
Primary outcome
The primary end point is the stone free rate at 3 months post ureteroscopy.
Time frame: 3 months post ureteroscopy
1 secondary outcome
Secondary end points include operative and surgical factors such as operative time, stone size, stone location, stone composition, patient sex and the presence of a ureteric stent post-op.
Time frame: at time of intervention
Results and safety
The study was stopped early (reason given: Enrollment was slower than anticipated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2009.
Related trials for Urinary Calculi
Not yet recruitingPhase 4
A Study on the Efficacy and Safety of Ningmitai Capsules in Treating Patients With Upper Urinary Tract Stones After Extracorporeal Shock Wave Lithotripsy
Calculus of Upper Urinary Tract
RecruitingObservational study
Stone Clearance With Aspiration vs Other Technologies: a Real-world Evidence Study
Urolithiasis, Stones, Kidney
Not yet recruiting
Intertransverse Process Block Versus Erector Spinae Plane Block for Postoperative Analgesia After Percutaneous Nephrolithotomy
Kidney Stones, Urolithiasis, Hypocitraturia, Pain, Postoperative
Not yet recruiting
Comparison of Smart Pressure-Controlled Flexible Ureteroscopy and Flexible Suction Ureteral Access Sheath-Assisted Flexible Ureteroscopy for 2-3 cm Renal Stones
Kidney Stones
Not yet recruitingEarly Phase 1
Phosphate & Kidney Stones
Kidney Stones, Calcium Oxalate Kidney Stones
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.
Hassan Razvi, MD, FRCSC principal investigator
Urology, St. Joseph's Hospital, The University of Western Ontario
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Navigator Ureteral Access Sheath in people with Urinary Calculi, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 5 sites 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 8 inclusion and 6 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: stopped early, as of the sponsor's last update on 14 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 stopped early (reason given: Enrollment was slower than anticipated.). Results are not available in the source record.
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?
The primary end point is the stone free rate at 3 months post ureteroscopy. (time frame: 3 months post ureteroscopy). 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 14 Oct 2009.