Temperature Profiles During Laser Activation in Ureteroscopic Lithotripsy

NCT05677425 | Completed Results

• 1 other identifier: 550816
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of this study is to investigate the temperature profiles in the renal pelvis during ureteroscopic Thulium Fiber Laser activation using different settings. To this end, comparison of peak temperatures during laser activation for different settings is the main aim. Secondary aim is trying to define the duration of safe laser activation until the threshold for heat induced cell injury (43oC) is reach. Patients ≥ 18 years with a ureteral stone (with or without a concomitant renal stone) and an indwelling nephrostomy tube scheduled for ureteroscopic lithotripsy at the day surgery unit at Haukeland University Hospital, are eligible to enrolment in the study. Temperature measurements during ureteroscopic laser stone disintegration will be performed. Follow-up is standardised with clinical consultation and low dose CT 3 months post endoscopically.

Conditions

Ureteral Stone

Outcome Measures

Primary Outcomes (1)

• Temperature Profiles

  Temperatures during ureteroscopic laser activation using different laser power settings.

  During surgery

Study Arms (1)

Temperature measurement group

EXPERIMENTAL

Temperature measurement in the renal pelvis during ureteroscopic laser stone disintegration. Temperature measurement will be performed using different laser power settings.

Other: Temperature measurement

Interventions

Temperature measurement OTHER

Temperature measurement in the renal pelvis during ureteroscopic laser activation.

Temperature measurement group

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 with a ureteral stone (with or without a concomitant renal stone) and an indwelling nephrostomy tube scheduled for URS lithotripsy at the Day Surgery unit at Haukeland University Hospital

You may not qualify if:

• 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

Location

Related Publications (1)

• AEsoy MS, Juliebo-Jones P, Beisland C, Ulvik O. Temperature Measurements During Flexible Ureteroscopic Laser Lithotripsy: A Prospective Clinical Trial. J Endourol. 2024 Apr;38(4):308-315. doi: 10.1089/end.2023.0660. Epub 2024 Feb 28.

  PMID: 38185920 DERIVED

MeSH Terms

Conditions

Ureterolithiasis

Condition Hierarchy (Ancestors)

Ureteral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; 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, Assoc Prof

  Haukeland University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients ≥ 18 years with a ureteral stone (with or without a concomitant renal stone) and an indwelling nephrostomy tube scheduled for URS lithotripsy at the Day Surgery unit at Haukeland University Hospital, can be enrolled in the study.

Study Record Dates

• First Submitted: December 29, 2022
• First Posted: January 10, 2023
• Study Start: January 23, 2023
• Primary Completion: June 30, 2023
• Study Completion: July 1, 2023
• Last Updated: April 11, 2025
• Results First Posted: March 24, 2025

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)