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NCT03220516 Clinical Trial

Single-use Digital Flexible Ureteroscope vs Nondisposable Fiber Optic vs Digital Ureteroscope

Urolithiasis Clinical Trial

Official title:
A Prospective Randomized Study Comparing Single-use Digital Flexible Ureteroscope, Nondisposable Fiber Optic and Digital Ureteroscope in Treatment of Upper Urinary Stone Less Than 2 cm

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03220516
Other study ID # Scopes compared
Secondary ID
Status Not yet recruiting
Phase N/A
First received July 1, 2017
Last updated July 16, 2017
Start date August 2017
Est. completion date September 2020

Study information
Verified date July 2017
Source The First Affiliated Hospital of Guangzhou Medical University
Contact Wei Zhu, PhD
Phone 008613622754991
Email doczw1989@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this trial is to compare the safety, efficacy and cost effectiveness of the three types of scopes.

Description:

With the advancement of technology, flexible ureteroscopy (f-URS) has become an attractive option for surgical management of kidney stones. However, the durability of flexible ureteroscope still remains a major concern. Due to the high cost and limited durability, the cost-benefit of non-disposable flexible ureteroscope continues to be the most important factor for initiating and maintaining fURS programs worldwide, especially in the developing countries. Nowadays, disposable digital flexible ureteroscopes are available, offering an improved image resolution, no need for sterilization and repair, and more economic.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 450
Est. completion date September 2020
Est. primary completion date September 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

1. Aged 18-70 years

2. American society of Anesthesiology (ASA) score 1 and 2

3. Renal or upper ureteral stone of diameter = 2.0 cm

Exclusion Criteria:

1. Ureteral stricture, renal or ureteral deformity

2. Pregnancy

3. Patients with chronic kidney disease, CKD (serum creatine> 177 umol/L)

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• single use digital ureteroscope
All participants in this arm will undergo RIRS using a single use digital ureteroscope.
• reusable fiberoptic ureteroscope
All participants under this arm will undergo RIRS using a reusable fiberoptic ureteroscope
• reusable digital flexible ureteroscope
All participants under this arm will undergo RIRS using reusable digital flexible ureteroscope

Locations
Country Name City State
n/a

Sponsors (3)
Lead Sponsor Collaborator
Guohua Zeng Dr. Lufti KIRDAR Kartal Research and training Hospital, Instanbul, Turkey, Siloam St.Trudpert Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary cost of surgery the total cost of the procedure intraoperative
Secondary Stone free rate 1month after surgery
Secondary stone free rate 3months after surgery
Secondary complication rates upto 3months
Secondary operative time intraoperative
Secondary operator's satisfaction with the scope on the scope or 1-10 intraoperative
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