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NCT06257368 Clinical Trial

TFL Driven Urinary System Treatment Study

Urologic Diseases Clinical Trial

— TFL-DUST  

Official title:
TFL-DUST Study TFL Driven Urinary System Treatment Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06257368
Other study ID # CP359
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 24, 2023
Est. completion date December 2025

Study information
Verified date February 2024
Source Coloplast A/S
Contact Jessica Heringer
Phone +33644287794
Email frhej@coloplast.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goal of this observational study is: To assess the use of Coloplast TFL Drive in daily practice To confirm: - the safety and efficacy of the Coloplast TFL Drive and its GUI (Graphical User Interface) with pre-embedded settings in Laser lithotripsy - the safety and efficacy of the Coloplast TFL Drive and its GUI with pre-embedded settings for enucleation of prostate as treatment of benign prostate hyperplasia - the safety and efficacy of the Coloplast TFL Drive and its GUI with pre-embedded settings for ablation of urological tumors

Recruitment information / eligibility
Status Recruiting
Enrollment 373
Est. completion date December 2025
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Any adult patient, for which TFL laser is indicated for treating a urological disease (e.g. kidney or ureteral stones, urological tumor, BPH (Benign Prostate Hypertrophy…) Exclusion Criteria: - Any condition when TFL laser should not be indicated as per the TFL user manual (untrained surgeon on laser use, patient's conditions) - Patients with no signed consent form - Patients <18 years old - Patients under tutorship or guardianship - Patients who already took part in the study - Pregnant or breastfeeding women - Patient undergoing 2nd step laser procedure at inclusion - Subject already included in another study

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Coloplast TFL Drive
Thulium Fiber laser

Locations
Country Name City State
France CHU Bordeaux Bordeaux
France Clinique Jules Verne Nantes
France Hôpital Tenon Paris
France Hôpital Privé Francheville Périgueux
Spain HM Hospital Sanchinarro Madrid

Sponsors (1)
Lead Sponsor Collaborator
Coloplast A/S

Countries where clinical trial is conducted

France,  Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Time in Laser ON day 1
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