Recruiting

LithoVue Elite

Sponsor:

Centre hospitalier de l'Université de Montréal (CHUM)

Code:

NCT04900688

Conditions

Kidney Stone

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

LithoVue Elite

Study Details

Brief 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.

Conditions

Kidney Stone

Study ID

NCT04900688

Start date

Jan 16, 2023

Status verified date

Jun, 2024

Completion date

Sep 15, 2025

Anticipated

Primary completion date

Mar 15, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

150 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

Interventions

LithoVue Elite

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

Primary outcome measure

  • WISQOL [ Time Frame: At baseline, 1-2 weeks after surgery and 4-8 weeks after surgery ]

Central Contacts and Locations

Central contacts

Naeem Dr Bhojani, MD

514-890-8000naeem.bhojani@gmail.com

Kahina Bensaadi, DESS

514-890-8000kahina.bensaadi.chum@ssss.gouv.qc.ca

Locations

Centre Hospitalier de l'Université de Montréal (CHUM)

Recruiting

Montréal, Quebec, Canada, H2X 3E4

Contacts

Naeem Bhojani, MD

514-890-8000naeem.bhojani@gmail.com

Kahina Bensaadi, DESS

514-890-8000kahina.bensaadi.chum@ssss.gouv.qc.ca

More Information

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Last update posted

Jun 7, 2024

Last verified

Jun, 2024

Keywords

  • renal stone, ureteroscopy, laser lithotrypsy, ureteroscope

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Centre hospitalier de l'Université de Montréal (CHUM) on 2024-06-07.