Laser Lithotripsy During URS - Holmium vs Thulium

Not Applicable

Completed

• Conditions: Urolithiasis
• Interventions: Device: Thulium Fiber laser machine

• Registration Number: NCT04668586
• Lead Sponsor: Haukeland University Hospital

Brief Summary

The aim of the study is to compare URS lithotripsy performed with Holmium:YAG laser and Thulium Fiber Laser.

The study is designed as a prospective clinical randomised trial, where the study participants are randomised to either URS with Holmium:YAG laser or URS with Thulium Fiber Laser.

The outcomes of the URS procedures are compared for the two treatment arms.

Detailed Description

The primary aim of the study is to compare the stone free rate (SFR) following URS lithotripsy with Holmium and Thulium lasers. SFRs will be compared both for ureteral stones, renal stones and ureteral and renal stones in total.

Secondary aims are to compare the results of the two lasers in terms of operating times, intraoperative complications, postoperative complications and the rate of post endoscopic JJ-stenting.

The study is designed as a prospective clinical randomised trial, where the study participants are randomised to either URS with Holmium:YAG laser or URS with Thulium Fiber Laser.

The outcomes of the URS procedures are compared for the two treatment arms.

Study Timeline

• Study First Submitted: 2020-12-06
• Study First Submitted QC: 2020-12-13
• Study First Posted: 2020-12-16
• Study Start: 2021-01-14
• Primary Completion: 2021-06-30
• Study Completion: 2021-10-31
• Status Verified: 2025-03
• Results First Submitted: 2025-03-03
• Results First Submitted QC: 2025-03-26
• Last Update Submitted: 2025-03-26
• Results First Posted: 2025-03-30
• Last Update Posted: 2025-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Patients planned for ureteroscopic treatment of ureteral and renal stones at the Day Surgery Unit at Haukeland University Hospital, Bergen, Norway

Exclusion Criteria

• Known pathology of the upper urinary tract
• Untreated infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Thulium Fiber laser machine	Thulium Fiber laser machine	The ureteral or renal stones planned for treatment with URS and laser lithotripsy are fragmented or dusted using a Thulium Fiber laser machine.

Primary Outcome Measures

Name	Time	Method
Stone Free Rate	3 months after the URS	Evaluation of stone free status on CT scan following URS. Stone free status is defined as no residual fragments.

Secondary Outcome Measures

Name	Time	Method
Operating Time	Decided immediately after the surgery	Surgical operating time
Intraoperative Complications	Decided immediately after the surgery	Intraoperative complications leading to abruption of the URS procedure
Postoperative Complications	Within 3 months post endoscopically	Postoperative complications (ie. infection, pain, stricture) leading to intervention or readmittance after the URS procedure.
Postoperative JJ-stenting	Decided immediately after the surgery	How many needed postendoscopic stunting following the URS procedure

Trial Locations

Locations (1)

Haukeland University Hospital; 🇳🇴 Bergen, Vestland, Norway