Study Results
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View full resultsBasic Information
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COMPLETED
NA
120 participants
INTERVENTIONAL
2021-01-14
2021-10-31
Brief Summary
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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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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
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.
Holmium:YAG laser machine
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.
Thulium Fiber laser machine
Ureteroscopy with Thulium Fiber laser lithotripsy
Interventions
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Holmium:YAG laser machine
Ureteroscopy with Holmium:YAG laser lithotripsy
Thulium Fiber laser machine
Ureteroscopy with Thulium Fiber laser lithotripsy
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Untreated infection
18 Years
ALL
No
Sponsors
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Haukeland University Hospital
OTHER
Responsible Party
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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
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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170907
Identifier Type: -
Identifier Source: org_study_id
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