Laser Lithotripsy During URS - Holmium vs Thulium

NCT ID: NCT04668586

Last Updated: 2025-03-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-14

Study Completion Date

2021-10-31

Brief Summary

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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

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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.

Conditions

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Urolithiasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Arm 1: Holmium:YAG laser lithotripsy Arm 2: Thulium Fiber laser lithotripsy
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
The patient is in narcosis when the designated treatment is decided by randomisation, and the treatment is about to start.

Study Groups

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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.

Group Type EXPERIMENTAL

Holmium:YAG laser machine

Intervention Type DEVICE

Ureteroscopy with Holmium:YAG laser lithotripsy

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.

Group Type EXPERIMENTAL

Thulium Fiber laser machine

Intervention Type DEVICE

Ureteroscopy with Thulium Fiber laser lithotripsy

Interventions

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Holmium:YAG laser machine

Ureteroscopy with Holmium:YAG laser lithotripsy

Intervention Type DEVICE

Thulium Fiber laser machine

Ureteroscopy with Thulium Fiber laser lithotripsy

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Haukeland University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Øyvind Ulvik, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Helse-Bergen HF, Haukeland University Hospital

Locations

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Haukeland University Hospital

Bergen, Vestland, Norway

Site Status

Countries

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Norway

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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170907

Identifier Type: -

Identifier Source: org_study_id

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