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

Guohua Zeng

Status: Unknown

Conditions: Urolithiasis

Treatments: Procedure: reusable digital flexible ureteroscope; Procedure: single use digital ureteroscope; Procedure: reusable fiberoptic ureteroscope

Study type: Interventional

Funder types: Other

Identifiers

NCT03220516

Scopes compared

Details and patient eligibility

About

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

Full 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.

Enrollment: 450 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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450 participants in 3 patient groups

single-use digital ureteroscope

Experimental group

Description:

Participants under this arm will undergo retrograde intrarenal surgery (RIRS) procedure under the single use digital ureteroscope.

Treatment:

Procedure: single use digital ureteroscope

reusable fiberoptic ureteroscopes

Experimental group

Description:

Participants under this arm will undergo the RIRS procedure under the reusable fiberoptic ureteroscope

Treatment:

Procedure: reusable fiberoptic ureteroscope

reusable digital flexible ureteroscopes

Experimental group

Description:

Participants under this arm will undergo the RIRS procedure under the reusable digital flexible ureteroscope.

Treatment:

Procedure: reusable digital flexible ureteroscope