NCT07566741

Brief Summary

Patients diagnosed with urolithiasis will be prospectively enrolled in this study. Preoperative diagnostic assessment will be performed using computed tomography (CT). Key parameters, including stone dimensions, quantity, total stone burden, and stone density (Hounsfield units), will be evaluated preoperatively. This study aims to analyze data from patients who undergo ureteroscopic Thulium Fiber Laser (TFL) lithotripsy and achieve a stone-free status within a single procedural session. Based on these data, a 'Specific Energy Coefficient' will be derived to enable the preoperative prediction of the total laser energy required for successful lithotripsy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 5, 2026

Completed
Last Updated

May 8, 2026

Status Verified

May 1, 2026

Enrollment Period

8 months

First QC Date

April 28, 2026

Last Update Submit

May 5, 2026

Conditions

Keywords

urolithiasisthulium fiber laserlithotripsysteno-freeenergy

Outcome Measures

Primary Outcomes (1)

  • thulium fiber laser energy consumption per mm3xHu

    4 weeks

Study Arms (1)

Stone-free

EXPERIMENTAL
Procedure: thulium fiber laser lithotripsy

Interventions

Procedures were performed by two high-volume experienced endourologists. Semirigid URS (7.5-9.5 F) was utilized for ureteral stones, while flexible URS (7.5 F) with a ureteral access sheath (10/12 F or 12/14 F) was preferred for renal stones. A 200 µm Thulium fiber was employed in all cases. Fragmentation was performed in Dusting Mode (Pulse Energy: 0.1-0.2 J, Frequency: 80-150 Hz).

Stone-free

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged 18 years and above
  • diagnosed with symptomatic urinary system stones
  • planned URS or fURS
  • normal upper urinary tract anatomy
  • achieved stone-free

You may not qualify if:

  • active urinary tract infection
  • history of surgery/DJ stent placement within the last six months
  • congenital renal anomalies
  • patients with residual fragments on postoperative evaluation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yozgat Bozok University Faculty of Medicine

Yozgat, Yozgat, 66100, Turkey (Türkiye)

Location

Related Publications (1)

  • Selmi V, Oztekin U, Caniklioglu M, Isikay L. Prediction of The Energy Required for Ho:YAG Laser Lithotripsy of Urinary Stones. Urol J. 2021 Apr 28;18(3):284-288. doi: 10.22037/uj.v18i.6442.

    PMID: 33931845BACKGROUND

MeSH Terms

Conditions

Urolithiasis

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • volkan selmi

    Yozgat Bozok University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 28, 2026

First Posted

May 5, 2026

Study Start

June 1, 2025

Primary Completion

January 31, 2026

Study Completion

January 31, 2026

Last Updated

May 8, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations