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NCT Number: NCT04668586

Laser Lithotripsy During URS - Holmium vs Thulium

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.

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Key information

Conditions

Urolithiasis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haukeland University Hospital

Bergen, Vestland, 5021, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Holmium:YAG laser machine

Device

Ureteroscopy with Holmium:YAG laser lithotripsy

Thulium Fiber laser machine

Device

Ureteroscopy with Thulium Fiber laser lithotripsy

Primary outcomes

  1. Stone Free Rate

    Time frame: 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 outcomes

  1. Operating Time

    Time frame: Decided immediately after the surgery

    Surgical operating time

  2. Intraoperative Complications

    Time frame: Decided immediately after the surgery

    Intraoperative complications leading to abruption of the URS procedure

  3. Postoperative Complications

    Time frame: Within 3 months post endoscopically

    Postoperative complications (ie. infection, pain, stricture) leading to intervention or readmittance after the URS procedure.

  4. Postoperative JJ-stenting

    Time frame: Decided immediately after the surgery

    How many needed postendoscopic stunting following the URS procedure

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 16, 2020
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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