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N/A N=180 Randomized Treatment

Comparing Treatment of Urolithiasis Between Disposable and Reusable Ureteroscope

Kidney Calculi · Ureter Calculi

Enrolled (actual)
180
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcome: Primary: Overall Procedure Time — 64.5; 54.1 minutes

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
reusable fiberoptic ureteroscope (Device); disposable digital ureteroscope (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of California, San Francisco
Primary completion
Sep 2016

Outcome Measures

OutcomeResultp-value
PRIMARY
Overall Procedure Time
64.5; 54.1
SECONDARY
Number of Participants That Are Stone Free
17; 24
SECONDARY
Number of Participants With Complications
9; 9

Summary

Reusable flexible ureteroscopes are widely used to treat various upper urinary tract diseases including urinary stones. However, they require a long turnover time between procedures because of the sterilization process. Moreover, repeated use of a scope ultimately deteriorates its image quality which leads to a high maintenance cost in the long-term. A disposable digital flexible ureteroscope was released in the United States in January 2016, offering an improved image resolution, new scope performance characteristics with every case, and no need for sterilization and repair. Preliminary data from our center has demonstrated that disposable scopes shorten operative time by 25% compared to reusable fiberoptic scope and are associated with a 2/3 reduction in procedural complication rate. Therefore, treatment with disposable scopes may be more effective for patients and facilitate cost management within the hospital. Here, we propose a three-armed, prospective randomized study, comparing treatment outcomes between disposable digital, reusable fiberoptic, and reusable digital flexible ureteroscopes.

Eligibility Criteria

Inclusion Criteria

  • Male or female ≥ 18 years of age at their first clinical visit.
  • Patients with either unilateral or bilateral upper urinary tract stone of any size and location, treatable by flexible ureteroscopy, diagnosed by preoperative ultrasound, computed tomography or plain radiographic imaging
  • Patients being able and willing to provide consent.

Exclusion Criteria

  • Serious illness likely to cause death within the next 5 years, so as to exclude significant metabolic derangements that might lead to adverse surgical outcome.
  • Pregnancy.
  • Staged ureteroscopic procedure.
  • Antegrade flexible ureteroscopy.
  • Dual procedures (ureteroscopy concurrently performed with other operations).
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03040466). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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