TFL Driven Urinary System Treatment Study
Recruiting
- Conditions
- Urologic Diseases
- Registration Number
- NCT06257368
- Lead Sponsor
- Coloplast A/S
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 373
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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time in Laser ON day 1
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
HM Hospital Sanchinarro
🇪🇸Madrid, Spain
CHU Bordeaux
🇫🇷Bordeaux, France
Hôpital Tenon
🇫🇷Paris, France
Clinique Jules Verne
🇫🇷Nantes, France
Hôpital Privé Francheville
🇫🇷Périgueux, France