Performance Proof of the New NORMA-SENSE | NCT00802763

Studies
Performance Proof of the New NORMA-SENSE

NCT00802763

Sponsor

Carmel Medical Center

Status

Unknown status

Last Update Posted

Dec 5, 2008Estimated

Enrollment

224Estimated

Phase

Not provided

Conditions

Vaginal Infection

Interventions

NORMA-SENSE

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2009

Primary Completion Date

Jul 2009Estimated

Completion Date

Aug 2009Estimated

First Submitted Date

Dec 4, 2008

First Submission Date that Met QC Criteria

Dec 4, 2008

First Posted Date

Dec 5, 2008Estimated

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

Dec 4, 2008

Last Update Posted Date

Dec 5, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

This study was designed to validate the color appearance on the newly developed panty liner (NORMA-SENSE). The NORMA-SENSE liner changes color when worn by the user and comes into contact with vaginal secretion with an elevated pH level, without false positives due to urine remains or incontinence. The study will also asses the physical comfort in using NORMA-SENSE and the result reading clarity which includes the ability to visualize and interpret the NORMA-SENSE strip results.

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

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

224Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
vaginitis			Device: NORMA-SENSE

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NORMA-SENSE	Device	Should be used by the clinician. the test usage will take up to 6 hours. The result reading will take few second.	vaginitis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
We will asses agreement between the color status of the NORMA-SENSE as reported by the subject after using the panty liner, and the pH measurement with Nitrazine paper.		1 week

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women, age 18 years or greater without symptoms of vaginal infection.
Subject is ready to sign the informed consent form.

Exclusion Criteria:

Subject is unable or unwilling to cooperate with study procedures.
Subject is currently participating in another clinical study.
Subject suffers from vaginal bleeding or is menstruating.
Subject that have had sexual relations within the last 12 hours.
Subject that applied local antiseptic or antibiotic or vaginal treatment within the last 3 days.
Subject that applied vaginal douching within 12 hours prior to the visit at the clinic.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Women, age greater then 18 without symptoms of vaginal infection.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
HADAR KESSARY, PhD	Contact	972-4-6277101		HADAR@CS-COMMONSENSE.COM

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Lin Medical center		Haifa			Israel	hadar kessary, PhD

Type	Date	Date Unknown
Release	Aug 10, 2009
Reset	Sep 15, 2009
Release	Sep 22, 2009
Reset	Sep 29, 2009
Release	Oct 18, 2009
Reset	Nov 25, 2009
Release	Dec 13, 2009
Reset	Jan 14, 2010
Release	Jan 31, 2010
Reset	Mar 2, 2010

Submission Tracking

Estimated Results First Submitted Date

Aug 10, 2009

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Aug 10, 2009			Sep 15, 2009
Sep 22, 2009

Condition Browse Module

MeSH Terms

ID	Term
D014627	Vaginitis

Ancestor Terms

ID	Term
D014623	Vaginal Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

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Browse Branches

Not provided