Prospective Evaluation of the LithoVue Elite Ureteroscope

NCT04900688 | Recruiting

• 1 other identifier: MP-02-2022-9937
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 6

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

Keywords

renal stone, ureteroscopy, laser lithotrypsy, ureteroscope

Outcome Measures

Primary Outcomes (1)

• WISQOL

  Change in quality of Life of patients living with kidney stones as assessed by the Winsconsin Stone Quality Of Life questionnaire

  At baseline, 1-2 weeks after surgery and 4-8 weeks after surgery

Secondary Outcomes (5)

• BPI

  at baseline, in the recovery room after surgery, 1-2 weeks after surgery and 4-8 weeks after surgery

• Stone free rate

  4-8 weeks after surgery

• Infectious Complications

  at 30 days after surgery

• Complications

  at 30 days after surgery

• Change in neutrophil gelatinase-associated lipocalin (NGAL) from baseline

  at baseline and in the recovery room after surgery

Study Arms (1)

Ureteroscopy (URS) with the LithoVue Elite disposable flexible ureteroscope

OTHER

Ureteroscopy will be done using the LithoVue Elite disposable flexible ureteroscope instead of the satandard ureteroscope

Device: LithoVue Elite

Interventions

LithoVue Elite DEVICE

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

Ureteroscopy (URS) with the LithoVue Elite disposable flexible ureteroscope

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• University of British Columbia: collaborator
• Western University, Canada: collaborator
• Université de Montréal: collaborator
• University of Saskatchewan: collaborator
• Laval University: collaborator

Study Sites (6)

Vancouver General Hospital

Vancouver, British Columbia, V6X 1Z9, Canada

NOT YET RECRUITING

Western University

London, Ontario, N6A 3K7, Canada

NOT YET RECRUITING

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2X 3E4, Canada

RECRUITING

Hôpital Maisonneuve-Rosemont (HMR)

Montreal East, Quebec, H1T2M4, Canada

NOT YET RECRUITING

CHU de Québec-Université Laval

Québec, Quebec, G1V4G2, Canada

NOT YET RECRUITING

University of Saskatchewan

Saskatoon, Saskatchewan, S7N5A8, Canada

NOT YET RECRUITING

Related Publications (3)

• Benli E, Ayyildiz SN, Cirrik S, Noyan T, Ayyildiz A, Cirakoglu A. Early term effect of ureterorenoscopy (URS) on the Kidney: research measuring NGAL, KIM-1, FABP and CYS C levels in urine. Int Braz J Urol. 2017 Sep-Oct;43(5):887-895. doi: 10.1590/S1677-5538.IBJU.2016.0638.

  PMID: 28792192 BACKGROUND

• Fahmy N, Sener A, Sabbisetti V, Nott L, Lang RM, Welk BK, Mendez-Probst CE, MacPhee RA, VanEerdewijk S, Cadieux PA, Bonventre JV, Razvi H. Urinary expression of novel tissue markers of kidney injury after ureteroscopy, shockwave lithotripsy, and in normal healthy controls. J Endourol. 2013 Dec;27(12):1455-62. doi: 10.1089/end.2013.0188. Epub 2013 Nov 1.

  PMID: 24180435 BACKGROUND

• Penniston KL, Antonelli JA, Viprakasit DP, Averch TD, Sivalingam S, Sur RL, Pais VM Jr, Chew BH, Bird VG, Nakada SY. Validation and Reliability of the Wisconsin Stone Quality of Life Questionnaire. J Urol. 2017 May;197(5):1280-1288. doi: 10.1016/j.juro.2016.11.097. Epub 2016 Nov 23.

  PMID: 27889419 BACKGROUND

MeSH Terms

Conditions

Kidney Calculi; Nephrolithiasis

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Naeem Dr Bhojani, MD

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Naeem Dr Bhojani, MD

CONTACT

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

Kahina Bensaadi, DESS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single arm multicenter study looking at real world results of ureteroscopy with the new digital flexible ureteroscope.

Study Record Dates

• First Submitted: May 20, 2021
• First Posted: May 25, 2021
• Study Start: January 16, 2023
• Primary Completion: March 15, 2025
• Study Completion: September 15, 2025
• Last Updated: June 7, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (6)