TFL Driven Urinary System Treatment Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

373 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-24

Study Completion Date

2025-12-31

Brief Summary

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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

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Detailed Description

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Conditions

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Urologic Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Coloplast TFL Drive

Thulium Fiber laser

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No