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

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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00199524

Enrollment

Registered

2005-09-20

Start date

2005-05-31

Completion date

2009-05-31

Last updated

2009-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Calculi

Keywords

ureteroscopy, stone free

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.

Interventions

DEVICENavigator Ureteral Access Sheath

ureteral access sheath

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
The primary end point is the stone free rate at 3 months post ureteroscopy.	3 months post ureteroscopy

Secondary

Measure	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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026