TFL Driven Urinary System Treatment Study (TFL-DUST)

Coloplast

Status: Enrolling

Conditions: Urologic Diseases

Treatments: Device: Coloplast TFL Drive

Study type: Observational

Funder types: Industry

Identifiers

NCT06257368

CP359

Details and patient eligibility

About

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

Enrollment: 373 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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