TFL Driven Urinary System Treatment Study (TFL-DUST)

February 13, 2024 updated by: Coloplast A/S

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

373

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Bordeaux, France, 33000
        • Recruiting
        • CHU Bordeaux
        • Contact:
          • Grégoire Robert, pr
      • Nantes, France, 44000
        • Recruiting
        • Clinique Jules Verne
        • Contact:
          • Victor Tostivint, MD
      • Paris, France
        • Recruiting
        • Hôpital Tenon
        • Contact:
          • Olivier Traxer, Pr
      • Périgueux, France, 24000
        • Recruiting
        • Hôpital privé Francheville
        • Contact:
          • Richard Mallet, Dr
  • Spain
      • Madrid, Spain
        • Recruiting
        • HM Hospital Sanchinarro
        • Contact:
          • Javier Romero-Otero, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adults patients, male and female with an urological disease for which TFL treatment is indicated.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time in Laser ON
Time Frame: day 1
day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Coloplast A/S

Investigators

  • Study Director: Isabelle D de Berny, Coloplast Manufacturing France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 24, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

February 6, 2024

First Submitted That Met QC Criteria

February 6, 2024

First Posted (Actual)

February 13, 2024

Study Record Updates

Last Update Posted (Estimated)

February 15, 2024

Last Update Submitted That Met QC Criteria

February 13, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP359

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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