Laser Lithotripsy During URS - Holmium vs Thulium

Laser Lithotripsy During Ureteroscopy - Holmium vs Thulium: A Clinical Prospective Randomized Trial of Effectiveness and Safety

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.

Study Overview

• Status: Completed
• Conditions: Urolithiasis
• Intervention / Treatment: Device: Holmium:YAG laser machine; Device: Thulium Fiber laser machine

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Vestland
    • Bergen, Vestland, Norway, 5021
      • Haukeland University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Holmium:YAG laser machine; The ureteral or renal stones planned for treatment with URS and laser lithotripsy are fragmented or dusted using a Holmium:YAG laser machine.	Device: Holmium:YAG laser machine; Ureteroscopy with Holmium:YAG laser lithotripsy
Experimental: 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.	Device: Thulium Fiber laser machine; Ureteroscopy with Thulium Fiber laser lithotripsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stone free rate	Evaluation of stone free status on CT scan following URS. Stone free status is defined as no residual fragments.	3 months after the URS

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Haukeland University Hospital
• Investigators: Principal Investigator: Øyvind Ulvik, MD PhD, Helse-Bergen HF, Haukeland University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2021
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): October 31, 2021

Study Registration Dates

• First Submitted: December 6, 2020
• First Submitted That Met QC Criteria: December 13, 2020
• First Posted (Actual): December 16, 2020

Study Record Updates

• Last Update Posted (Actual): January 27, 2022
• Last Update Submitted That Met QC Criteria: January 26, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Urolithiasis
• Other Study ID Numbers: 170907

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: IPF will not be available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No