NCT00803127

Brief Summary

This study is designed to demonstrate the result reading clarity of the VS-SENSE is substantially equivalent to the result reading clarity of the Nitrazine pH Paper test for vaginal secretions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2009

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 4, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 5, 2008

Completed
27 days until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

August 11, 2009

Status Verified

August 1, 2009

Enrollment Period

3 months

First QC Date

December 4, 2008

Last Update Submit

August 10, 2009

Conditions

Vaginitis

Keywords

vaginal infection, color appearance

Outcome Measures

Primary Outcomes (1)

  • The clinician reports of the VS-SENSE test results, the pH measurement by Nitrazine Paper test records, and the results reading clarity grade from the clinician.

    5 minuts

Study Arms (1)

no treament

Device: vs-sense

Interventions

vs-senseDEVICE

detection swab

no treament

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Symptomatic and asymptomatic women, ages 18 and above.

You may qualify if:

  • Symptomatic women, ages 18 and above.
  • Subjects willing and able to sign the informed consent form.

You may not qualify if:

  • Subjects are unable or unwilling to cooperate with study procedures.
  • Subjects are currently participating in other clinical study that may directly or indirectly affect the results of this study.
  • Women with blood present in their vaginal secretion.
  • Subjects that have had sexual relations or applied vaginal douched within the previous 12 hours.
  • Subjects that applied vaginal medications within the last 3 days.
  • Subjects with symptoms and signs of pelvic inflammatory disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lin Medical center

Haifa, West Galil, Israel

Location

Biospecimen

Retention: SAMPLES WITH DNA

VAGINAL DISCHARGE

MeSH Terms

Conditions

Vaginitis

Condition Hierarchy (Ancestors)

Vaginal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 4, 2008

First Posted

December 5, 2008

Study Start

January 1, 2009

Primary Completion

April 1, 2009

Study Completion

May 1, 2009

Last Updated

August 11, 2009

Record last verified: 2009-08

Locations

IL(1)