ClinicalTrials.Veeva

Menu

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

L

Lawson Health Research Institute

Status and phase

Terminated
Phase 4

Conditions

Urinary Calculi

Treatments

Device: Navigator Ureteral Access Sheath

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00199524
R-05-002

Details and patient eligibility

About

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.

Enrollment

44 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

44 participants in 2 patient groups

1
Active Comparator group
Description:
ureteroscopy with ureteral access sheath
Treatment:
Device: Navigator Ureteral Access Sheath
2
No Intervention group
Description:
ureteroscopy without ureteral access sheath

Trial contacts and locations

5

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems