Trials / Unknown
UnknownNCT06257368
TFL Driven Urinary System Treatment Study
TFL-DUST Study TFL Driven Urinary System Treatment Study
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 373 (estimated)
- Sponsor
- Coloplast A/S · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Coloplast TFL Drive | Thulium Fiber laser |
Timeline
- Start date
- 2023-07-24
- Primary completion
- 2024-12-01
- Completion
- 2025-12-01
- First posted
- 2024-02-13
- Last updated
- 2024-02-15
Locations
5 sites across 2 countries: France, Spain
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06257368. Inclusion in this directory is not an endorsement.