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Efficacy and safety of Thulium fiber laser versus holmium: YAG laser combined with the flexible and navigable suction access sheath in flexible ureteroscopic lithotripsy for kidney stones of 2 to 3 cm: a single-center prospective randomized clinical trial

Efficacy and safety of disposable flexible ureteroscope combined with flexible sheath laser in the treatment of upper urinary tract calculi assisted by intelligent pressure control stone removal system

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500106365
Enrollment
Unknown
Registered
2025-07-23
Start date
2025-08-20
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney stone

Interventions

Holmium Laser Group:Transurethral ureteroscopic holmium laser lithotripsy combined with flexible negative pressure suction sheath and intelligent perfusion suction platform
Thulium fiber laser:Transurethral ureteroscopic thulium laser lithotripsy combined with a flexible negative pressure suction sheath and an intelligent perfusion suction platform

Sponsors

Affiliated Hospital of Nantong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Aged 18 to 80 years; Preoperative non-contrast CT (NCCT) showed a simple kidney stone (maximum stone diameter 2-3 cm); normal upper urinary tract anatomy; provision of written informed consent and agreement to complete a one-month follow-up assessment.

Exclusion criteria

Exclusion criteria: Major comorbidities contraindicating general anesthesia; Irreversible coagulation dysfunction; untreated urinary tract infection; concurrent ureteral calculi; pregnancy; nephrolithiasis in transplanted kidneys;Infectious stones; urothelial neoplasms; spinal deformities; anatomical abnormalities of the urinary system (such as severe ureteral stricture, ureteropelvic junction stricture, duplicated ureter, horseshoe kidney, duplex kidney, etc.); participation in other clinical trials within 30 days prior to study initiation or during the study period; inability to provide informed consent; other conditions contraindicating laser lithotripsy.

Design outcomes

Primary

MeasureTime frame
operative time;—

Secondary

MeasureTime frame
total laser activation time;total laser energy;ablation efficiency;Visual Field Clarity Score;Stone Retropulsion Severity Score;Immediate postoperative SFR;30-day postoperative SFR;Intraoperative and 30-day postoperative complications;Hematuria Severity Score at 2 Hours Postoperatively;Creatinine Elevation Value on the First Day Postoperatively;Hemoglobin Decrease Value on the First Day Postoperatively;Leukocyte Elevation Value on the First Day Postoperatively;—

Countries

China

Contacts

Public ContactZhao Fan

Affiliated Hospital of Nantong University

zhaofan@ntu.edu.cn+86 158 5120 5126

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 7, 2026