TFL Driven Urinary System Treatment Study

Launched by COLOPLAST A/S · Feb 6, 2024

Keywords

ClinConnect Summary

The TFL Driven Urinary System Treatment Study is designed to evaluate the Coloplast TFL Drive, a tool used in treating various urologic diseases, such as kidney stones and prostate enlargement. This study aims to understand how safe and effective this tool is when used in everyday medical practice for procedures like laser treatment of urological tumors and prostate issues. If you are an adult aged 65 or older with a urological condition that requires laser treatment, you might be eligible to participate.

Participants in this study can expect to undergo the usual treatment they would receive, using the TFL Drive under the care of trained medical professionals. The study is currently looking for volunteers, but there are certain criteria that could prevent someone from participating, such as being under 18 years old, being pregnant or breastfeeding, or having other medical conditions that make the laser treatment unsuitable. Your involvement will help doctors learn more about this technology and improve treatment options for patients with urological diseases.

Gender

ALL

Eligibility 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