Reliability of Home Uroflowmetery Using a Disposable Digi... | NCT02026674

Studies
Reliability of Home Uroflowmetery Using a Disposable Digital Device

NCT02026674

Sponsor

Flometrica Ltd.

Status

Unknown status

Last Update Posted

Jan 14, 2014Estimated

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Lower Urinary Tract Symptoms

Interventions

FloRite

Countries

Israel

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

Jan 2014

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

Dec 2013

Primary Completion Date

Dec 2014Estimated

Completion Date

Not provided

First Submitted Date

Dec 24, 2013

First Submission Date that Met QC Criteria

Jan 1, 2014

First Posted Date

Jan 3, 2014Estimated

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

Jan 13, 2014

Last Update Posted Date

Jan 14, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The FloRite™ device is a disposable urine flow meter, indicated for use in a home setting.

The device provides Urofowmetry measurements, similar to clinic's measurements. Clinic-based uroflowmetry has some flaws; the setting is artificial and often it is difficult to void at the desired moment. Moreover, a single measurement of the voided parameters is a poor representative of the patient condition due to high variability of the measured parameters. Performing multiple Urofowmetry measurements provides representative and more accurate results, in a more patient-friendly, cost effective method.

Detailed Description

The FloRite™ product is a disposable urine flow meter. The patient needs to urinate into the device and at the end of urination the patient needs to disconnect a USB drive from the device, dispose the device's container and keep the USB drive that contains the test data.

Primary objectives:

• Usability evaluation of the FloRite™ system with LUTS patients.

Secondary objectives:

Comparison of uroflowmetric parameters obtained using home disposable digital uroflowmetry device with standard clinic-based uroflowmetry.
Evaluation of diurnal variations in uroflowmetric parameters obtained using home uroflowmetry

Primary outcome measures

• Successful use of FloRite™ system in LUTS patients, defined as:

Successful unpacking and installation
Successful understanding of the user manual
Ability of the patients to operate the device as define by a successful test completion and data transmission
Successful retrieval of the DOK
Absence of:
Device dropping down
Urination outside the container
Urination on the electronic unit

Secondary outcome measures:

• Comparison of uroflowmetric parameters as measured by

FloRite™ system and standard clinical uroflowmetry as defined by [Time Frame: Days 0, 1, 6 and 7]:

Qmax - Max Flow Rate

• Evaluation of diurnal variations in uroflowmetric parameters obtained using home uroflowmetry as defined by [Time Frame: Days 1, 6]:
Urine flow graph
Tdelay - Delay time
T100 - Voiding Time
TQ - Flow Time
Tqmax - Time to max Flow
Qmax - Max Flow Rate
Qave - Average Flow Rate
Vcomp - Voided Volume Up to 30 completed patients

Inclusion criteria

LUTS patients
Male 18\

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
FloRite	Experimental	LUTS patients that used FloRite for home urine flow diagnostics.	Device: FloRite

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FloRite	Device	Disposable home use urine flow meter.	FloRite

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Usability evaluation of the FloRite™ system with LUTS patients.	Primary outcome measures • Successful use of FloRite™ system in LUTS patients, defined as: Successful unpacking and installation Successful understanding of the user manual Ability of the patients to operate the device as define by a successful test completion and data transmission Successful retrieval of the DOK Absence of: Device dropping down Urination outside the container Urination on the electronic unit	Dec-2014

Secondary Outcomes

Measure	Description	Time Frame
Comparison of Qmax (Max Flow Rate)	Comparison of uroflowmetric parameters of Qmax as measured by FloRite™ system and standard clinical uroflowmetry [Time Frame: Days 0, 1, 6 and 7].	Dec-2014
Comparison of Tdelay

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

LUTS patients
Male 18\

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Zeev Cohen, M.Sc.	Contact	+972-52-4471297		zeev@flometrica.cm

Overall Officials

Name	Affiliation	Role
Ilan Leibovitch, Prof.	Meir Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
"Meir" Hospital	Recruiting	Kfar Saba			Israel

Condition Browse Module

MeSH Terms

ID	Term
D059411	Lower Urinary Tract Symptoms
D011470	Prostatic Hyperplasia

Ancestor Terms

ID	Term
D020924	Urological Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D011469	Prostatic Diseases

Browse Leaves

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Browse Branches

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