TFL Driven Urinary System Treatment Study
TFL-DUST
TFL-DUST Study TFL Driven Urinary System Treatment Study
1 other identifier
observational
373
2 countries
5
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2023
Typical duration for all trials
5 active sites
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
July 24, 2023
CompletedFirst Submitted
Initial submission to the registry
February 6, 2024
CompletedFirst Posted
Study publicly available on registry
February 13, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedFebruary 15, 2024
February 1, 2024
1.4 years
February 6, 2024
February 13, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Time in Laser ON
day 1
Interventions
Thulium Fiber laser
Eligibility Criteria
Adults patients, male and female with an urological disease for which TFL treatment is indicated.
You may qualify if:
- 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…)
You may not qualify if:
- 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
- Subject already included in another study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Coloplast A/Slead
Study Sites (5)
CHU Bordeaux
Bordeaux, 33000, France
Clinique Jules Verne
Nantes, 44000, France
Hôpital Tenon
Paris, France
Hôpital Privé Francheville
Périgueux, 24000, France
HM Hospital Sanchinarro
Madrid, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Isabelle D de Berny
Coloplast Manufacturing France
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 6, 2024
First Posted
February 13, 2024
Study Start
July 24, 2023
Primary Completion
December 1, 2024
Study Completion
December 1, 2025
Last Updated
February 15, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share