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Laser Lithotripsy During URS - Holmium vs Thulium

Primary Purpose

Urolithiasis

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Holmium:YAG laser machine
Thulium Fiber laser machine
Sponsored by
Haukeland University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urolithiasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Haukeland University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Holmium:YAG laser machine

Thulium Fiber laser machine

Arm Description

The ureteral or renal stones planned for treatment with URS and laser lithotripsy are fragmented or dusted using a Holmium:YAG 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Operating time
Surgical operating time
Intraoperative complications
Intraoperative complications leading to abruption of the URS procedure
Postoperative complications
Postoperative complications (ie. infection, pain, stricture) leading to intervention or readmittance after the URS procedure.
Postoperative JJ-stenting
How many needed postendoscopic stunting following the URS procedure

Full Information

First Posted
December 6, 2020
Last Updated
January 26, 2022
Sponsor
Haukeland University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04668586
Brief Title
Laser Lithotripsy During URS - Holmium vs Thulium
Official Title
Laser Lithotripsy During Ureteroscopy - Holmium vs Thulium: A Clinical Prospective Randomized Trial of Effectiveness and Safety
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
January 14, 2021 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
October 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Haukeland University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urolithiasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Arm 1: Holmium:YAG laser lithotripsy Arm 2: Thulium Fiber laser lithotripsy
Masking
Participant
Masking Description
The patient is in narcosis when the designated treatment is decided by randomisation, and the treatment is about to start.
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Holmium:YAG laser machine
Arm Type
Experimental
Arm Description
The ureteral or renal stones planned for treatment with URS and laser lithotripsy are fragmented or dusted using a Holmium:YAG laser machine.
Arm Title
Thulium Fiber laser machine
Arm Type
Experimental
Arm Description
The ureteral or renal stones planned for treatment with URS and laser lithotripsy are fragmented or dusted using a Thulium Fiber laser machine.
Intervention Type
Device
Intervention Name(s)
Holmium:YAG laser machine
Intervention Description
Ureteroscopy with Holmium:YAG laser lithotripsy
Intervention Type
Device
Intervention Name(s)
Thulium Fiber laser machine
Intervention Description
Ureteroscopy with Thulium Fiber laser lithotripsy
Primary Outcome Measure Information:
Title
Stone free rate
Description
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
Secondary Outcome Measure Information:
Title
Operating time
Description
Surgical operating time
Time Frame
Decided immediately after the surgery
Title
Intraoperative complications
Description
Intraoperative complications leading to abruption of the URS procedure
Time Frame
Decided immediately after the surgery
Title
Postoperative complications
Description
Postoperative complications (ie. infection, pain, stricture) leading to intervention or readmittance after the URS procedure.
Time Frame
Within 3 months post endoscopically
Title
Postoperative JJ-stenting
Description
How many needed postendoscopic stunting following the URS procedure
Time Frame
Decided immediately after the surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Øyvind Ulvik, MD PhD
Organizational Affiliation
Helse-Bergen HF, Haukeland University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Haukeland University Hospital
City
Bergen
State/Province
Vestland
ZIP/Postal Code
5021
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPF will not be available to other researchers.

Learn more about this trial

Laser Lithotripsy During URS - Holmium vs Thulium

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