High Versus Low Power Settings During Ureteroscopic Laser Lithotripsy

NCT05697250 | Recruiting

• 1 other identifier: 550740
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of the study is to compare the operative times following ureteroscopic lithotripsy for renal stones with Thulium Fiber Laser using low and high power settings. Secondary aims are to compare the results of low and high power settings in terms of stone free rates, laser time, laser activation patterns, intraoperative and postoperative complications. Patients ≥ 18 years with renal stones (8-25 mm) scheduled for ureteroscopic lithotripsy at the Day Surgery Clinic at Haukeland University Hospital in Bergen, Norway, are eligible for inclusion in the study. After written consent and inclusion, patients are randomised to laser lithotripsy using either low power settings (Group 1: 4-6 Watt, short pulse mode) or high power settings (Group 2: 16-18 Watt, short pulse mode). The ureteroscopic procedures are performed in general anaesthesia using a standardised technique. All patients are followed up with a low dose CT scan 3 months post endoscopically to assess stone free status as well as a consultation at the outpatient clinic. Results and data for the two randomisation groups are compared according to the aims of the study.

Conditions

Renal Stone

Outcome Measures

Primary Outcomes (1)

• Operative time

  Surgical time in minutes, counted from start of the procedure with insertion of the cystoscope until emptying the bladder in the end.

  During surgery (approximately 1 hour), registered immediately after surgery

Secondary Outcomes (5)

• Stone free rate

  3 months post endoscopically

• Laser activation patterns - duration

  During surgery (approximately 1 hour), registered immediately after surgery

• Laser activation patterns - number

  During surgery (approximately 1 hour), registered immediately after surgery

• Intraoperative complications

  During surgery (approximately 1 hour), registered immediately after surgery

• Post operative complications

  After surgery until 3 months post endoscopically.

Study Arms (2)

Group 1 - low power laser settings

EXPERIMENTAL

4-6 Watts, short pulse mode. 0.4 - 0.6 J at 10 Hz.

Other: Laser power settings (Thulium Fiber Laser)

Group 2 - high power laser settings

EXPERIMENTAL

16-18 Watts, short pulse mode. 0.4 J / 40 Hz, 0.6 J / 30 Hz or 0.8 J / 20 Hz.

Other: Laser power settings (Thulium Fiber Laser)

Interventions

Laser power settings (Thulium Fiber Laser) OTHER

Ureteroscopic lithotripsy using low power laser settings (0.4 - 0.6 J at 10 Hz corresponding to 2.4 - 6.0 Watts) or high power laser settings (0.4 J at 40 Hz, 0.6 J at 30 Hz or 0.8 J at 20 Hz corresponding to 16 - 18 Watts).

Group 1 - low power laser settings; Group 2 - high power laser settings

Eligibility Criteria

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

You may qualify if:

• Patients ≥ 18 years scheduled for URS lithotripsy for renal stones, 8-25 mm, at the day surgery unit at Haukeland University Hospital

You may not qualify if:

• Concomitant ureteral stone
• Urinary diversion
• Active infection
• Untreated cancer in the upper urinary tract

Sponsors & Collaborators

• Haukeland University Hospital: lead

Study Sites (1)

Haukeland University Hospital

Bergen, Vestland, 5021, Norway

RECRUITING

MeSH Terms

Conditions

Nephrolithiasis

Condition Hierarchy (Ancestors)

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

Study Officials

• Øyvind Ulvik, Assoc Prof

  Haukeland University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Øyvind Ulvik, Assoc Prof

CONTACT

+47 90918595; doc.ulvik@online.no

Mathias S Æsøy, MD

CONTACT

mathias.asoy@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Stone free status is assessed on low dose CT 3 months post endoscopically by an outcome assessor blinded to the randomisation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The patients are randomised to ureteroscopic stone treatment with Thulium Fiber Laser with either low or high laser settings. The ureteroscopic procedures are performed in a standardised manner irrespective of the laser settings, and follow-up is similar in both groups.

Study Record Dates

• First Submitted: December 29, 2022
• First Posted: January 25, 2023
• Study Start: January 23, 2023
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: March 5, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)