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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Holmium:YAG laser machine | Experimental | The ureteral or renal stones planned for treatment with URS and laser lithotripsy are fragmented or dusted using a Holmium:YAG laser machine. |
|
| Thulium Fiber laser machine | Experimental | The ureteral or renal stones planned for treatment with URS and laser lithotripsy are fragmented or dusted using a Thulium Fiber laser machine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Holmium:YAG laser machine | Device | Ureteroscopy with Holmium:YAG laser lithotripsy |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Øyvind Ulvik, MD PhD | Helse-Bergen HF, Haukeland University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haukeland University Hospital | Bergen | Vestland | 5021 | Norway |
IPF will not be available to other researchers.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Thulium Fiber Laser Machine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Stone Free Rate | Evaluation of stone free status on CT scan following URS. Stone free status is defined as no residual fragments. | Posted | Count of Participants | Participants | 3 months after the URS |
|
From surgery until 3 months folloe-up
Adverse events reported according to Clavien-Dindo classification
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Postoperative complications | Renal and urinary disorders | Clavien-Dindo | Systematic Assessment | Adverse Events were monitored/assessed in such a manner that the specific Adverse Event Terms cannot be separated. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Øyvind Ulvik | Haukeland University Hospital | +47 97 50 00 | doc.ulvik@online.no |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 5, 2020 | Mar 3, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D052878 | Urolithiasis |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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Arm 1: Holmium:YAG laser lithotripsy Arm 2: Thulium Fiber laser lithotripsy
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The patient is in narcosis when the designated treatment is decided by randomisation, and the treatment is about to start.
| Thulium Fiber laser machine | Device | Ureteroscopy with Thulium Fiber laser lithotripsy |
|
| 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 |
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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Stone size | Patients had either renal stones (n = 75) or ureteral stones (n = 45). The total number of participants were 120 (overall) | Median | Inter-Quartile Range | mm |
|
| Stone location | The total number of participants is 120. Some participants had stones in the renal pelvis (n=75) and some had stones in the ureter (n=45). The sum of participants with stones in the renal pelvis and ureter is 120. | Number | participants |
|
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|
|
| Secondary | Operating Time | Surgical operating time | Posted | Median | Inter-Quartile Range | minutes | Decided immediately after the surgery |
|
|
|
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| Secondary | Intraoperative Complications | Intraoperative complications leading to abruption of the URS procedure | Posted | Count of Participants | Participants | Decided immediately after the surgery |
|
|
|
| Secondary | Postoperative Complications | Postoperative complications (ie. infection, pain, stricture) leading to intervention or readmittance after the URS procedure. | Posted | Count of Participants | Participants | Within 3 months post endoscopically |
|
|
|
|
| Secondary | Postoperative JJ-stenting | How many needed postendoscopic stunting following the URS procedure | Posted | Count of Participants | Participants | Decided immediately after the surgery |
|
|
|
|
| 0 |
| 60 |
| 0 |
| 60 |
| 8 |
| 60 |
| EG001 | 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 | 0 | 60 | 0 | 60 | 7 | 60 |
|
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| D052801 | Male Urogenital Diseases |
| Obstruction |
|
| Other |
|