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Completed

NCT Number: NCT00803127

VS-Sense Result Reading Clarity

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.

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Key information

Conditions

Vaginitis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Urogenital Diseases Vaginal Diseases

Age range

18 year–70 year

Sex eligibility

Female

Study type

Observational

Primary location

Lin Medical center

Haifa, West Galil, Israel

About this study

Once informed consent has been signed, the clinician will perform the following:

Record baseline variables in the CRF. The 1st clinician will obtain a vaginal secretion sample by using the VS-SENSE swab. The 1st clinician will obtain the specimen by separating the labia to expose the vagina. The yellow tip of the VS-SENSE swab will be inserted into the vagina approximately 5 cm/ 2". The 1st clinician will use the VS-SENSE according the instructions for use - attachment 1 to the protocol.

The 1st clinician will read the VS-SENSE results and record them on the designated form (Clinician Report - VS-SENSE Result form), and fill out the table regarding the VS-SENSE reading clarity on the same form.Vaginal examination (including speculum examination) - will be performed by a 2nd clinician, masked from the results of the 1st clinician test.

The 2nd clinician will use a vaginal swab for pH measurement by Nitrazine pH Paper test. The Nitrazine pH Paper test will be performed according to strict manufacturer's instruction.

The 2nd clinician will read the results of the Nitrazine pH Paper test result, document it on the Clinician Report - pH Test Result form, and fill out the table regarding the pH test reading clarity on the same form.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

vs-sense

Device

detection swab

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.

    Time frame: 5 minuts

Sponsors and collaborators

Lead sponsor

Carmel Medical Center

Other

Collaborators

  • Common Sense
  • Lin Medical Center, Haifa

Registry information

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Dec 5, 2008
Registry last updated
Aug 11, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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