Use of a Ureteral Access Sheath During Ureteroscopy and Its Effect on Stone Free Rate

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective Randomized Controlled Clinical Trial of the Use of a Ureteral Access Sheath During Ureteroscopy and Its Effect on Stone Free Rate

Conditions
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Urinary Calculi

Intervention / Treatment
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* Device: Navigator Ureteral Access Sheath


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>ureteroscopy with ureteral access sheath | Device: Navigator Ureteral Access Sheath<br>* ureteral access sheath<br>* Other names: Navigator Ureteral Access Shealth;|
| No Intervention: 2<br>ureteroscopy without ureteral access sheath | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary end point is the stone free rate at 3 months post ureteroscopy. |  | 3 months post ureteroscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | at time of intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ureteroscopy, stone free