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NCT04668586 Clinical Trial

Laser Lithotripsy During URS - Holmium vs Thulium

Urolithiasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04668586
Other study ID # 170907
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 14, 2021
Est. completion date October 31, 2021

Study information
Verified date January 2022
Source Haukeland University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date October 31, 2021
Est. primary completion date June 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Holmium:YAG laser machine
Ureteroscopy with Holmium:YAG laser lithotripsy
• Thulium Fiber laser machine
Ureteroscopy with Thulium Fiber laser lithotripsy

Locations
Country Name City State
Norway Haukeland University Hospital Bergen Vestland

Sponsors (1)
Lead Sponsor Collaborator
Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Secondary Operating time Surgical operating time Decided immediately after the surgery
Secondary Intraoperative complications Intraoperative complications leading to abruption of the URS procedure Decided immediately after the surgery
Secondary Postoperative complications Postoperative complications (ie. infection, pain, stricture) leading to intervention or readmittance after the URS procedure. Within 3 months post endoscopically
Secondary Postoperative JJ-stenting How many needed postendoscopic stunting following the URS procedure Decided immediately after the surgery
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