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

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Canada
Western University
NOT_YET_RECRUITING
London
Centre Hospitalier de l'Université de Montréal (CHUM)
RECRUITING
Montreal
Hôpital Maisonneuve-Rosemont (HMR)
NOT_YET_RECRUITING
Montreal East
CHU de Québec-Université Laval
NOT_YET_RECRUITING
Québec
University of Saskatchewan
NOT_YET_RECRUITING
Saskatoon
Vancouver General Hospital
NOT_YET_RECRUITING
Vancouver
Contact Information
Primary
Naeem Dr Bhojani, MD
naeem.bhojani@gmail.com
514-890-8000
Backup
Kahina Bensaadi, DESS
kahina.bensaadi.chum@ssss.gouv.qc.ca
514-890-8000
Time Frame
Start Date: 2023-01-16
Estimated Completion Date: 2025-09-15
Participants
Target number of participants: 150
Treatments
Other: Ureteroscopy (URS) with the LithoVue Elite disposable flexible ureteroscope
Ureteroscopy will be done using the LithoVue Elite disposable flexible ureteroscope instead of the satandard ureteroscope
Related Therapeutic Areas
Sponsors
Collaborators: Université de Montréal, University of British Columbia, Western University, Canada, Laval University, University of Saskatchewan
Leads: Centre hospitalier de l'Université de Montréal (CHUM)

This content was sourced from clinicaltrials.gov