A Prospective Randomized Controlled Clinical Trial of the Use of a Ureteral Access Sheath During Ureteroscopy and Its Effect on Stone Free Rate
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Enrollment
- 44
- Locations
- 5
- Primary Endpoint
- The primary end point is the stone free rate at 3 months post ureteroscopy.
Study Overview
Brief 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. 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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
1
ureteroscopy with ureteral access sheath
Intervention: Navigator Ureteral Access Sheath (Device)
2
ureteroscopy without ureteral access sheath
Outcomes
Primary Outcomes
The primary end point is the stone free rate at 3 months post ureteroscopy.
Time Frame: 3 months post ureteroscopy
Secondary Outcomes
- 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)