TFL Driven Urinary System Treatment Study

Last updated: February 13, 2024
Sponsor: Coloplast A/S
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Coloplast TFL Drive

Clinical Study ID

NCT06257368
CP359
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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

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

Total Participants: 373
Treatment Group(s): 1
Primary Treatment: Coloplast TFL Drive
Phase:
Study Start date:
July 24, 2023
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • CHU Bordeaux

    Bordeaux, 33000
    France

    Active - Recruiting

  • Clinique Jules Verne

    Nantes, 44000
    France

    Active - Recruiting

  • Hôpital Tenon

    Paris,
    France

    Active - Recruiting

  • Hôpital Privé Francheville

    Périgueux, 24000
    France

    Active - Recruiting

  • HM Hospital Sanchinarro

    Madrid,
    Spain

    Active - Recruiting

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