Feasibility Study of the NEW NORMA-SENSE | NCT00324246

Studies
Feasibility Study of the NEW NORMA-SENSE

NCT00324246

Sponsor

Carmel Medical Center

Status

Completed

Last Update Posted

Jun 20, 2008Estimated

Enrollment

160Actual

Phase

Not provided

Conditions

Vaginal Infection

Interventions

Not provided

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

ID	Type	Description	Link
CMC 06014008

Status Module

Record Verification Date

Jan 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2006

Primary Completion Date

Not provided

Completion Date

Dec 2007Actual

First Submitted Date

May 9, 2006

First Submission Date that Met QC Criteria

May 9, 2006

First Posted Date

May 10, 2006Estimated

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

Jun 19, 2008

Last Update Posted Date

Jun 20, 2008Estimated

Name	Class
Lin Medical Center, Haifa	OTHER
Common Sense	OTHER

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

In-vitro study
Collect data regarding the color appearance on the new developed indicator strips (NEW NORMA-SENSE), in contact with vaginal secretion with elevated pH
Measure the buffering capacity of vaginal secretion from non-symptomatic and symptomatic subjects
Detect these indicator strips' performance, in contact with urine

Detailed Description

This in-vitro study was designed to collect data regarding the color appearance on the new developed indicator strips (NEW NORMA-SENSE) when coming in contact, in-vitro, with vaginal secretion with elevated pH, and to measure the buffering capacity of vaginal secretion from non-symptomatic subjects and symptomatic subjects, and to detect these indicator strips' performance when come in contact with urine.

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

160Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women, aged between 18 and 45, with or without symptoms of vaginal infection.
Subjects are ready to sign the informed consent form.

Exclusion Criteria:

Subjects are unable or unwilling to cooperate with the study procedures.
Subjects are currently participating in another clinical study that may directly or indirectly affect the results of this study.
Subjects that suffer from vaginal bleeding or menstruate.
Subjects that have had sexual relations within the last 12 hours.
Subjects that applied local antiseptic, antibiotic or vaginal treatment within the last 3 days.
Subjects 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

45 Years

Standard Ages

Adult

Study Population

Women, age between 18 years and 45 years with or without symptoms of vaginal infection.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Adam Geva, MD	Women Health Care Center - Lin Medical Center, Haifa, Israel	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Women Health Care Center - Lin Medical Center		Haifa			Israel

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

Not provided

Browse Branches

Not provided