Vaginal InfectionNCT00802763
Performance Proof of the New NORMA-SENSE
An observational study of Vaginal Infection, run by Carmel Medical Center at 1 site in Israel.
Trial summary
This study was designed to validate the color appearance on the newly developed panty liner (NORMA-SENSE). The NORMA-SENSE liner changes color when worn by the user and comes into contact with vaginal secretion with an elevated pH level, without false positives due to urine remains or incontinence. 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
- Vaginal Infection
- What is being tested?
- NORMA-SENSE
- Type of treatment
- Medical device
- How many people
- 224 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2009to Aug 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: Women, age greater then 18 without symptoms of vaginal infection.
Who may be able to join
- Women, age 18 years or greater without symptoms of vaginal infection.
- Subject is ready to sign the informed consent form.
Who cannot join
- Subject is unable or unwilling to cooperate with study procedures.
- Subject is currently participating in another clinical study.
- Subject suffers from vaginal bleeding or is menstruating.
- Subject that have had sexual relations within the last 12 hours.
- Subject that applied local antiseptic or antibiotic or vaginal treatment within the last 3 days.
- Subject that applied vaginal douching within 12 hours prior to the visit at the clinic.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Lin Medical center
Haifa
hadar kessary, PhD, 972-4-6277101, HADAR@CS-COMMONSENSE.COM
Adam Geva, MD
About this study
Official title: Performance Proof of the New NORMA-SENSE Panty Liner - in-Vivo STUD
This study was designed to validate the color appearance on the newly developed panty liner (NORMA-SENSE). The NORMA-SENSE liner changes color when worn by the user and comes into contact with vaginal secretion with an elevated pH level, without false positives due to urine remains or incontinence. The study will also asses the physical comfort in using NORMA-SENSE and the result reading clarity which includes the ability to visualize and interpret the NORMA-SENSE strip results.
- Conditions
- Vaginal Infection
- Being tested
- NORMA-SENSE
- Keywords
- VAGINAL INFECTION, COLOR APPEARANCE, ELEVATED Ph
- Medical subject headings
- Vaginitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NORMA-SENSEDevice
Should be used by the clinician. the test usage will take up to 6 hours. The result reading will take few second.
| Study group | Role | What they receive |
|---|---|---|
| vaginitis | Not described Receives: Device: NORMA-SENSE |
What is being measured
The primary outcome is the main question the study is designed to answer.
We will asses agreement between the color status of the NORMA-SENSE as reported by the subject after using the panty liner, and the pH measurement with Nitrazine paper.
Measured: 1 week
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 startFeb 2009
- Primary completionJul 2009 (estimated)
- Study completionAug 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaginal InfectionStudies 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
- Retrospective
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carmel Medical Center
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00802763
- Sponsor's protocol ID
- F-7-28.1-1 VER-2
- Status last verified
- Dec 2008
- First submitted
- 4 Dec 2008
- Last updated
- 5 Dec 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Proof of the New NORMA-SENSE Panty Liner - in-Vivo STUD
- ClinicalTrials.gov ID
- NCT00802763
- Acronym / sponsor ID
- F-7-28.1-1 VER-2
- Conditions
- Vaginal Infection
- Keywords
- VAGINAL INFECTION, COLOR APPEARANCE, ELEVATED Ph
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- Carmel Medical CenterUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Jul 2009 (estimated)
- Study completion
- Aug 2009 (estimated)
- 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 was designed to validate the color appearance on the newly developed panty liner (NORMA-SENSE). The NORMA-SENSE liner changes color when worn by the user and comes into contact with vaginal secretion with an elevated pH level, without false positives due to urine remains or incontinence. The study will also asses the physical comfort in using NORMA-SENSE and the result reading clarity which includes the ability to visualize and interpret the NORMA-SENSE strip results.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| vaginitis | – | Device: NORMA-SENSE |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women, age greater then 18 without symptoms of vaginal infection.
Key inclusion criteria (2 listed)
- Women, age 18 years or greater without symptoms of vaginal infection.
- Subject is ready to sign the informed consent form.
Key exclusion criteria (6 listed)
- Subject is unable or unwilling to cooperate with study procedures.
- Subject is currently participating in another clinical study.
- Subject suffers from vaginal bleeding or is menstruating.
- Subject that have had sexual relations within the last 12 hours.
- Subject that applied local antiseptic or antibiotic or vaginal treatment 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 |
|---|---|---|
| NORMA-SENSEShould be used by the clinician. the test usage will take up to 6 hours. The result reading will take few second. | Device | vaginitis |
Primary outcome
We will asses agreement between the color status of the NORMA-SENSE as reported by the subject after using the panty liner, and the pH measurement with Nitrazine paper.
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2008.
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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.
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 Vaginal Infection, 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: status not confirmed, as of the sponsor's last update on 5 Dec 2008. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact HADAR KESSARY, PhD (972-4-6277101, HADAR@CS-COMMONSENSE.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
We will asses agreement between the color status of the NORMA-SENSE as reported by the subject after using the panty liner, and the pH measurement with Nitrazine paper. (time frame: 1 week). 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 5 Dec 2008.