RecruitingNot ApplicableNCT04900688

Prospective Evaluation of the LithoVue Elite Ureteroscope

First Clinical Evaluation of the New Flexible Disposable Ureteroscope (LithoVue Elite): A Multicenter Single-arm Prospective Trial


Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Enrollment

150 participants

Start Date

Jan 16, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Flexible ureteroscopy has become the main surgical treatment for kidney stone disease. The procedure uses many types of ureteroscopes (disposable and non-disposable). Currently we are using the LithoVue Single-Use Digital Flexible Ureteroscope. The Health Canada approved LithoVue Elite disposable flexible ureteroscope will now offer novel pressure sensory capacity. In order to evaluate the new ureteroscopy we will be conducting a prospective multi-institution study in order to determine the main features, capacity and abilities of the new scope. We will evaluate the impact of intra renal pressure on pain, quality of life and possible infectious complications.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • Patient scheduled for ureteroscopy and laser lithotripsy
  • Non-obstructing renal stone 2 cm total stone diameter (if multiple stones, then sum of maximum diameters) or less undergoing flexible ureteroscopy
  • age > 18 years

Exclusion Criteria5

  • age < 18 years
  • pregnancy status =positive
  • indwelling nephrostomy tube
  • severe hydronephrosis that in the opinion of the investigator, will make it challenging to make the patient stone free
  • renal anomalies

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Interventions

DEVICELithoVue Elite

LithoVue Elite is a disposable flexible ureteroscope that offer novel pressure sensory capacity


Locations(6)

Vancouver General Hospital

Vancouver, British Columbia, Canada

Western University

London, Ontario, Canada

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, Canada

Hôpital Maisonneuve-Rosemont (HMR)

Montreal East, Quebec, Canada

CHU de Québec-Université Laval

Québec, Quebec, Canada

University of Saskatchewan

Saskatoon, Saskatchewan, Canada

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NCT04900688


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