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TFL Driven Urinary System Treatment Study

NCT06257368 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 373

Last updated 2024-02-15

No results posted yet for this 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

Conditions

  • Urologic Diseases

Interventions

DEVICE

Coloplast TFL Drive

Thulium Fiber laser

Sponsors & Collaborators

  • Coloplast A/S

    lead INDUSTRY

Principal Investigators

  • Isabelle D de Berny · Coloplast Manufacturing France

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-24
Primary Completion
2024-12-31
Completion
2025-12-31
FDA Device
Yes

Countries

  • France
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06257368 on ClinicalTrials.gov