Evaluation of a new disposable ureteroscope for kidney stone treatment
First Clinical Evaluation of the New Flexible Disposable Ureteroscope (LithoVue Elite): A Multicenter Single-arm Prospective Trial
This study is testing a new disposable ureteroscope to see if it works better than regular ones for treating kidney stones in patients undergoing a specific procedure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre hospitalier de l'Université de Montréal (CHUM) Academic / other |
| Locations | 6 sites (Vancouver, British Columbia and 5 other locations) |
| Trial ID | NCT04900688 on ClinicalTrials.gov |
What this trial studies
This study evaluates the LithoVue Elite disposable flexible ureteroscope in patients undergoing ureteroscopy and laser lithotripsy for kidney stones. It is a single-arm, multicenter trial involving six institutions, aiming to assess the ureteroscope's performance compared to standard devices. The study will measure outcomes such as stone-free rates, postoperative pain, quality of life, and infection rates, while also examining the impact of intra-renal pressure during the procedure. A total of 150 participants will be recruited, with each site responsible for 25 patients.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 scheduled for ureteroscopy and laser lithotripsy with non-obstructing renal stones measuring 20 mm or less.
Not a fit: Patients with indwelling nephrostomy tubes or severe hydronephrosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved outcomes and reduced complications for patients undergoing treatment for kidney stones.
How similar studies have performed: Other studies have shown success with similar ureteroscope evaluations, but this specific device's performance is being assessed for the first time.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Vancouver, British Columbia and 5 other locations
- Vancouver General Hospital — Vancouver, British Columbia, Canada (Not_yet_recruiting)
- Western University — London, Ontario, Canada (Not_yet_recruiting)
- Centre Hospitalier de l'Université de Montréal (CHUM) — Montreal, Quebec, Canada (Recruiting)
- Hôpital Maisonneuve-Rosemont (HMR) — Montreal East, Quebec, Canada (Not_yet_recruiting)
- CHU de Québec-Université Laval — Québec, Quebec, Canada (Not_yet_recruiting)
- University of Saskatchewan — Saskatoon, Saskatchewan, Canada (Not_yet_recruiting)
Study contacts
- Principal investigator: Naeem Dr Bhojani, MD — Centre hospitalier de l'Université de Montréal (CHUM)
- Study coordinator: Naeem Dr Bhojani, MD
- Email: naeem.bhojani@gmail.com
- Phone: 514-890-8000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.