Feasibility Study of the NEW NORMA-SENSE

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-09-30

Study Completion Date

2007-12-31

Brief Summary

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* 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

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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.

Conditions

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Vaginal Infection

Keywords

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vaginal infection color appearance new developed indicator strips (NEW NORMA-SENSE) in-vitro vaginal secretion elevated pH

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

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common sense

Principal Investigators

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Adam Geva, MD

Role: PRINCIPAL_INVESTIGATOR

Women Health Care Center - Lin Medical Center, Haifa, Israel

Locations

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Women Health Care Center - Lin Medical Center

Haifa, , Israel

Site Status

Countries

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Israel

Other Identifiers

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CMC 06014008

Identifier Type: -

Identifier Source: secondary_id

F-7-28-1 CTIL