Laser Lithotripsy During URS - Holmium vs Thulium

NCT04668586 | Completed Results

• 1 other identifier: 170907
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Urolithiasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Operating Time

  Decided immediately after the surgery

• Intraoperative Complications

  Decided immediately after the surgery

• Postoperative Complications

  Within 3 months post endoscopically

• Postoperative JJ-stenting

  Decided immediately after the surgery

Study Arms (2)

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.

Device: 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.

Device: Thulium Fiber laser machine

Interventions

Holmium:YAG laser machine DEVICE

Ureteroscopy with Holmium:YAG laser lithotripsy

Holmium:YAG laser machine

Thulium Fiber laser machine DEVICE

Ureteroscopy with Thulium Fiber laser lithotripsy

Thulium Fiber laser machine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients planned for ureteroscopic treatment of ureteral and renal stones at the Day Surgery Unit at Haukeland University Hospital, Bergen, Norway

You may not qualify if:

• Known pathology of the upper urinary tract
• Untreated infection

Sponsors & Collaborators

• Haukeland University Hospital: lead

Study Sites (1)

Haukeland University Hospital

Bergen, Vestland, 5021, Norway

Location

MeSH Terms

Conditions

Urolithiasis

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Øyvind Ulvik
• Organization: Haukeland University Hospital

doc.ulvik@online.no

+47 97 50 00

Study Officials

• Øyvind Ulvik, MD PhD

  Helse-Bergen HF, Haukeland University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patient is in narcosis when the designated treatment is decided by randomisation, and the treatment is about to start.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: December 6, 2020
• First Posted: December 16, 2020
• Study Start: January 14, 2021
• Primary Completion: June 30, 2021
• Study Completion: October 31, 2021
• Last Updated: March 30, 2025
• Results First Posted: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)