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Laser Lithotripsy During URS - Holmium vs Thulium

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04668586
Enrollment
120
Registered
2020-12-16
Start date
2021-01-14
Completion date
2021-10-31
Last updated
2025-03-30

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

Conditions

Urolithiasis

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.

Interventions

DEVICEHolmium:YAG laser machine

Ureteroscopy with Holmium:YAG laser lithotripsy

DEVICEThulium Fiber laser machine

Ureteroscopy with Thulium Fiber laser lithotripsy

Sponsors

Haukeland University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

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

Intervention model description

Arm 1: Holmium:YAG laser lithotripsy Arm 2: Thulium Fiber laser lithotripsy

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Stone Free Rate3 months after the URSEvaluation of stone free status on CT scan following URS. Stone free status is defined as no residual fragments.

Secondary

MeasureTime frameDescription
Operating TimeDecided immediately after the surgerySurgical operating time
Intraoperative ComplicationsDecided immediately after the surgeryIntraoperative complications leading to abruption of the URS procedure
Postoperative ComplicationsWithin 3 months post endoscopicallyPostoperative complications (ie. infection, pain, stricture) leading to intervention or readmittance after the URS procedure.
Postoperative JJ-stentingDecided immediately after the surgeryHow many needed postendoscopic stunting following the URS procedure

Countries

Norway

Participant flow

Participants by arm

ArmCount
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. Holmium:YAG laser machine: Ureteroscopy with Holmium:YAG laser lithotripsy
60
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. Thulium Fiber laser machine: Ureteroscopy with Thulium Fiber laser lithotripsy
60
Total120

Baseline characteristics

CharacteristicThulium Fiber Laser MachineTotalHolmium:YAG Laser Machine
Age, Continuous53 years53 years54 years
Race and Ethnicity Not Collected—0 Participants—
Region of Enrollment
Norway
60 participants60 participants60 participants
Sex: Female, Male
Female
22 Participants43 Participants21 Participants
Sex: Female, Male
Male
38 Participants77 Participants39 Participants
Stone location
Renal stones - all other locations
14 participants28 participants14 participants
Stone location
Renal stones - lower calyx
22 participants47 participants25 participants
Stone location
Ureteral stones - lower
16 participants25 participants9 participants
Stone location
Ureteral stones - middle
2 participants3 participants1 participants
Stone location
Ureteral stones - upper
6 participants17 participants11 participants
Stone size
Renal stones
12 mm12 mm12 mm
Stone size
Ureteral stones
8 mm8 mm7 mm

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 600 / 60
other
Total, other adverse events
8 / 607 / 60
serious
Total, serious adverse events
0 / 600 / 60

Outcome results

Primary

Stone Free Rate

Evaluation of stone free status on CT scan following URS. Stone free status is defined as no residual fragments.

Time frame: 3 months after the URS

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Holmium:YAG Laser MachineStone Free Rate34 Participants
Thulium Fiber Laser MachineStone Free Rate47 Participants
p-value: <0.006Chi-squared
Secondary

Intraoperative Complications

Intraoperative complications leading to abruption of the URS procedure

Time frame: Decided immediately after the surgery

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Holmium:YAG Laser MachineIntraoperative Complications0 Participants
Thulium Fiber Laser MachineIntraoperative Complications0 Participants
Secondary

Operating Time

Surgical operating time

Time frame: Decided immediately after the surgery

ArmMeasureValue (MEDIAN)
Holmium:YAG Laser MachineOperating Time60 minutes
Thulium Fiber Laser MachineOperating Time49 minutes
p-value: 0.008t-test, 2 sided
Secondary

Postoperative Complications

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

Time frame: Within 3 months post endoscopically

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Holmium:YAG Laser MachinePostoperative ComplicationsTotal participants needing readmission8 Participants
Holmium:YAG Laser MachinePostoperative ComplicationsInfection6 Participants
Holmium:YAG Laser MachinePostoperative ComplicationsObstruction2 Participants
Holmium:YAG Laser MachinePostoperative ComplicationsOther1 Participants
Thulium Fiber Laser MachinePostoperative ComplicationsOther1 Participants
Thulium Fiber Laser MachinePostoperative ComplicationsTotal participants needing readmission7 Participants
Thulium Fiber Laser MachinePostoperative ComplicationsObstruction4 Participants
Thulium Fiber Laser MachinePostoperative ComplicationsInfection4 Participants
p-value: 1Chi-squared
Secondary

Postoperative JJ-stenting

How many needed postendoscopic stunting following the URS procedure

Time frame: Decided immediately after the surgery

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Holmium:YAG Laser MachinePostoperative JJ-stenting31 Participants
Thulium Fiber Laser MachinePostoperative JJ-stenting22 Participants
p-value: 0.09Chi-squared, Corrected

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026