Using Coloplast TFL Drive for treating urologic diseases
TFL-DUST Study TFL Driven Urinary System Treatment Study
This study is testing how well the Coloplast TFL Drive works for treating different urologic conditions in adults and how safe it is to use in real-life situations.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 373 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Coloplast A/S Industry-sponsored |
| Locations | 5 sites (Bordeaux and 4 other locations) |
| Trial ID | NCT06257368 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the use of the Coloplast TFL Drive in clinical practice for various urologic conditions. It will assess the safety and efficacy of the device and its graphical user interface (GUI) in procedures such as laser lithotripsy, prostate enucleation for benign prostate hyperplasia, and ablation of urological tumors. The study will involve adult patients for whom TFL laser treatment is indicated, gathering data on outcomes and experiences in real-world settings.
Who should consider this trial
Good fit: Ideal candidates include adult patients indicated for TFL laser treatment of urological diseases like kidney stones or benign prostate hyperplasia.
Not a fit: Patients who are under 18, pregnant, or have conditions contraindicated for TFL laser use will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the safety and effectiveness of laser treatments for urologic diseases.
How similar studies have performed: While this approach is observational, similar studies assessing the efficacy of laser treatments in urology have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bordeaux and 4 other locations
- CHU Bordeaux — Bordeaux, France (Recruiting)
- Clinique Jules Verne — Nantes, France (Recruiting)
- Hôpital Tenon — Paris, France (Recruiting)
- Hôpital Privé Francheville — Périgueux, France (Recruiting)
- HM Hospital Sanchinarro — Madrid, Spain (Recruiting)
Study contacts
- Study coordinator: Jessica Heringer
- Email: frhej@coloplast.com
- Phone: +33644287794
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.