LithoVue Single Use Disposable Ureteroscope
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Nephrology, Nephrology |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 19 - Any |
| Updated: | 2/3/2018 |
| Start Date: | December 1, 2017 |
| End Date: | April 1, 2019 |
Prospective Trial of a Reusable Digital Flexible Ureteroscope vs a Single-Use Flexible Ureteroscope in the Treatment of Urolithiasis: An EDGE Consortium Clinical Trial
Most flexible ureteroscopes that are used to treat kidney stones have been reusable.
Recently, advances in technology have resulted in single-use (disposable) ureteroscopes to
become available. The investigators are interested in determining if the performance of the
two types of scopes are equivalent. This will help guide institutions in the future to
purchase the best scopes for their patients.
Recently, advances in technology have resulted in single-use (disposable) ureteroscopes to
become available. The investigators are interested in determining if the performance of the
two types of scopes are equivalent. This will help guide institutions in the future to
purchase the best scopes for their patients.
Ureteroscopy is commonly used in the treatment of kidney stones. Flexible ureteroscopes are
costly to purchase and repair. Issues with flexible ureteroscopes include loss of deflection
and visual performance (fiberoptic pixels) with use and the high repair costs. Reprocessing
and sterilization of reusable ureteroscopes also requires staff who are specially trained and
dedicated in this area. Inadequate sterilization could also lead to transmissible infections
between patients. A single-use flexible digital ureteroscope has recently become commercially
available (LithoVue, Boston Scientific, Marlborough, MA). Pre-clinical testing show the
accessibility to the ureter and all areas of the kidney to be equivalent to current flexible
ureteroscopes. However, clinical data comparing this single-use ureteroscope to a current
state of the art reusable ureteroscope is lacking. Establishing at least equivalence in
performance between the new single use ureteroscope and a reusable digital ureteroscope will
help surgeons and operating room managers/administrators help determine how to most
efficiently equip their operating rooms with endoscopic equipment.
costly to purchase and repair. Issues with flexible ureteroscopes include loss of deflection
and visual performance (fiberoptic pixels) with use and the high repair costs. Reprocessing
and sterilization of reusable ureteroscopes also requires staff who are specially trained and
dedicated in this area. Inadequate sterilization could also lead to transmissible infections
between patients. A single-use flexible digital ureteroscope has recently become commercially
available (LithoVue, Boston Scientific, Marlborough, MA). Pre-clinical testing show the
accessibility to the ureter and all areas of the kidney to be equivalent to current flexible
ureteroscopes. However, clinical data comparing this single-use ureteroscope to a current
state of the art reusable ureteroscope is lacking. Establishing at least equivalence in
performance between the new single use ureteroscope and a reusable digital ureteroscope will
help surgeons and operating room managers/administrators help determine how to most
efficiently equip their operating rooms with endoscopic equipment.
Inclusion Criteria:
- patients scheduled for ureteroscopy and laser lithotripsy for individual renal stones
ranging in size from 5 mm to 20 mm in all intrarenal locations (If there are multiple
stones present, the total stone burden in cross section should not exceed 20 mm)
- 19 years or older and able to provide informed consent
Exclusion Criteria:
- patients < 18 years
- pregnant
- patients with known nephrocalcinosis .
- any other reason that in the opinion of the investigator would make the participant
unsuitable for enrollment in the study.
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