Clinical Trial: The efficacy and safety of thulium fiber laser and flexible and navigable suction ureteral access sheath in retrograde intrarenal surgery for renal stone, compared with conventional access sheath: A Japanese multicenter prospective randomized controlled trial (TFLFANSJapan trial) (Japan)

Tokyo, Aug. 28 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058906) titled 'The efficacy and safety of thulium fiber laser and flexible and navigable suction ureteral access sheath in retrograde intrarenal surgery for renal stone, compared with conventional access sheath: A Japanese multicenter prospective randomized controlled trial (TFLFANSJapan trial)' on Aug. 27.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - Clinical Research Management Department, Yotsuya Medical Cube

Condition: Condition - renal stone Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study aims to compare the efficacy and safety of thulium fiber laser and flexible and navigable suction ureteral access sheath in retrograde intrarenal surgery for renal stone, compared with conventional access sheath. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - thulium fiber laser and flexible and navigable suction ureteral access sheath in retrograde intrarenal surgery for renal stone Interventions/Control_2 - thulium fiber laser and conventional access sheath in retrograde intrarenal surgery for renal stone

Eligibility: Age-lower limit - 1 years-old

Gender - Male and Female Key inclusion criteria - Patient with renal stones (stone diameter 10-20 mm) (if multiple renal stones are present, the largest diameter must be 10-20 mm) Patient deemed eligible for one stage RIRS Patient for whom written consent to participate in this study has been obtained from the patient themselves, their guardian, or authorized representative Key exclusion criteria - Patient with anomaly genitourinary system Patient with ureteral stone Target Size - 130

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 06 Month 06 Day Date of IRB - 2025 Year 06 Month 06 Day Anticipated trial start date - 2025 Year 09 Month 01 Day Last follow-up date - 2030 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067368

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