Urologic DiseasesTFL-DUSTNCT06257368
TFL Driven Urinary System Treatment Study
An observational study of Urologic Diseases, run by Coloplast A/S at 5 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urologic Diseases
- What is being tested?
- Coloplast TFL Drive
- Type of treatment
- Medical device
- How many people
- 373 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 24 Jul 2023to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults patients, male and female with an urological disease for which TFL treatment is indicated.
Who may be able to join
- 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…)
Who cannot join
- 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
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
France4 sites, 4 recruiting
- Recruiting
CHU Bordeaux
Bordeaux, 33000
Grégoire Robert, pr
- Recruiting
Clinique Jules Verne
Nantes, 44000
Victor Tostivint, MD
- Recruiting
Hôpital Tenon
Paris
Olivier Traxer, Pr
- Recruiting
Hôpital Privé Francheville
Périgueux, 24000
Richard Mallet, Dr
Spain1 site, 1 recruiting
- Recruiting
HM Hospital Sanchinarro
Madrid
Javier Romero-Otero, Dr
About this study
Official title: TFL-DUST Study TFL Driven Urinary System Treatment Study
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
- Being tested
- Coloplast TFL Drive
- Medical subject headings
- Urologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coloplast TFL DriveDevice
Thulium Fiber laser
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in Laser ON
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start24 Jul 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urologic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 373 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Isabelle D de Berny, Study director, Coloplast Manufacturing France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06257368
- Sponsor's protocol ID
- CP359
- Acronym
- TFL-DUST
- Status last verified
- Feb 2024
- First submitted
- 6 Feb 2024
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TFL-DUST Study TFL Driven Urinary System Treatment Study
- ClinicalTrials.gov ID
- NCT06257368
- Acronym / sponsor ID
- TFL-DUST / CP359
- Conditions
- Urologic Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 373 participants (estimated)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- 24 Jul 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 13 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults patients, male and female with an urological disease for which TFL treatment is indicated.
Key inclusion criteria (1 listed)
- 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…)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coloplast TFL DriveThulium Fiber laser | Device | – |
Primary outcome
Time in Laser ON
Time frame: day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabelle D de Berny study director
Coloplast Manufacturing France
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urologic Diseases, run by Coloplast A/S at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jessica Heringer (+33644287794, frhej@coloplast.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in Laser ON (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2024.