VaginitisNCT00803127
VS-Sense Result Reading Clarity
An observational study of Vaginitis, run by Carmel Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vaginitis
- What is being tested?
- vs-sense
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2009to May 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Symptomatic and asymptomatic women, ages 18 and above.
Who may be able to join
- Symptomatic women, ages 18 and above.
- Subjects willing and able to sign the informed consent form.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Vaginitis
- Being tested
- vs-sense
- Keywords
- vaginal infection, color appearance
- Medical subject headings
- Vaginitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vs-senseDevice
detection swab
| Study group | Role | What they receive |
|---|---|---|
| no treament | Not described Receives: Device: vs-sense |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 minuts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2008 (estimated)
- Study startJan 2009
- Primary completionApr 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VaginitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carmel Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Lin Medical Center, Haifa, Common Sense
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00803127
- Sponsor's protocol ID
- F-7-25.2-1
- Status last verified
- Aug 2009
- First submitted
- 4 Dec 2008
- Last updated
- 11 Aug 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VS-Sense Result Reading Clarity
- ClinicalTrials.gov ID
- NCT00803127
- Acronym / sponsor ID
- F-7-25.2-1
- Conditions
- Vaginitis
- Keywords
- vaginal infection, color appearance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Carmel Medical CenterUniversity, hospital or other
- Collaborators
- Lin Medical Center, Haifa, Common Sense
- Study start
- Jan 2009
- Primary completion
- Apr 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 5 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| no treament | – | Device: vs-sense |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Symptomatic and asymptomatic women, ages 18 and above.
Key inclusion criteria (2 listed)
- Symptomatic women, ages 18 and above.
- Subjects willing and able to sign the informed consent form.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vs-sensedetection swab | Device | no treament |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vaginitis, run by Carmel Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2009; AzTrials last refreshed its copy on 30 Oct 2026.