Urologic Diseases
Conditions
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
Interventions
DEVICEColoplast TFL Drive
Thulium Fiber laser
Sponsors
Coloplast A/S
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time in Laser ON | day 1 |
Countries
France, Spain
Contacts
Primary ContactJessica Heringer
Outcome results
None listed