TFL Driven Urinary System Treatment Study | NCT06257368

Studies
TFL Driven Urinary System Treatment Study

NCT06257368

Sponsor

Coloplast A/S

Status

Unknown status

Last Update Posted

Feb 15, 2024Actual

Enrollment

373Estimated

Phase

Not provided

Conditions

Urologic Diseases

Interventions

Coloplast TFL Drive

Countries

France
Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 24, 2023Actual

Primary Completion Date

Dec 2024Estimated

Completion Date

Dec 2025Estimated

First Submitted Date

Feb 6, 2024

First Submission Date that Met QC Criteria

Feb 6, 2024

First Posted Date

Feb 13, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 13, 2024

Last Update Posted Date

Feb 15, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

373Estimated

Name	Type	Description	Arm Group Labels	Other Names
Coloplast TFL Drive	Device	Thulium Fiber laser

Measure	Description	Time Frame
Time in Laser ON		day 1

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jessica Heringer	Contact	+33644287794		frhej@coloplast.com

Overall Officials

Name	Affiliation	Role
Isabelle D de Berny	Coloplast Manufacturing France	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Bordeaux	Recruiting	Bordeaux		33000	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014570	Urologic Diseases

Ancestor Terms

ID	Term
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D052801	Male Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided