Vaginal InfectionNCT01542606
Performance Proof of Product Developed to Detect Abnormal Vaginal pH
A study testing NORMA-SENSE in people with Vaginal Infection, run by Common Sense at 1 site in Israel.
Trial summary
This study was designed to validate the color appearance on the NORMA-SENSE gen 3 when comes into contact with vaginal secretions having an elevated pH level Read more about this study
- Who is it for?
- Ages 18 to 65 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2019to Dec 2019
- Phase
- Interventional
- 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women, age 18 years or greater with or 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.
About this study
Official title: Performance Proof of The Norma-Sense Gen 3 - Wearing Study
This study was designed to validate the color appearance on the NORMA-SENSE gen 3 when comes into contact with vaginal secretions having an elevated pH level
Read the detailed description
This study was designed to validate the color appearance on the NORMA-SENSE gen 3. The NORMA-SENSE gen 3 changes color when worn by the user and comes into contact with vaginal secretions having 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 gen 3 and the result reading clarity which includes the ability to visualize and interpret the NORMA-SENSE gen 3 results.
- Conditions
- Vaginal Infection
- Being tested
- NORMA-SENSE
- Keywords
- PH, SCREENING, EARLY WARNING, VAGINAL HEALTH, VAGINAL SECRETION, VAGINAL 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
The NORMA-SENSE gen 3 polymer matrix is stained by blue or green color on a pale yellow background when the pH level of the fluid in contact with it is greater than the cutoff value, and the user can consider any stain of color, which is different from the original background, as a positive result of the test.
| Study group | Role | What they receive |
|---|---|---|
| color status | Experimental | The NORMA-SENSE gen 3 polymer matrix is stained by blue or green color on a pale yellow background when the pH level of the fluid in contact with it is greater than the cutoff value, and the user can consider any stain of color, which is different from the original background, as a positive result of the test. Receives: Device: NORMA-SENSE |
What is being measured
The primary outcome is the main question the study is designed to answer.
color status of the NORMA-SENSE gen 3 and the pH measurement.
agreement between the color status of the NORMA-SENSE gen 3 as reported by the subject after using the panty liners, and the pH measurement with Nitrazine paper.
Measured: 3 days
Secondary outcomes (1)
physical comfort in using NORMA-SENSE gen 3 and the result reading clarity
the patient report regarding physical comfort in using NORMA-SENSE gen 3 and the result reading clarity including the ability to visualize and interpret the NORMA-SENSE gen 3 results.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2012 (estimated)
- Study startMar 2019 (estimated)
- Primary completionSep 2019 (estimated)
- Study completionDec 2019 (estimated)
Why it stopped: Internal decision of the sponsor
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Common Sense
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hadar Kessary, PhD, Study director, Common Sense
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01542606
- Sponsor's protocol ID
- F-7-28.6-1
- Status last verified
- Aug 2019
- First submitted
- 21 Feb 2012
- Last updated
- 31 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Proof of The Norma-Sense Gen 3 - Wearing Study
- ClinicalTrials.gov ID
- NCT01542606
- Acronym / sponsor ID
- F-7-28.6-1
- Conditions
- Vaginal Infection
- Keywords
- PH, SCREENING, EARLY WARNING, VAGINAL HEALTH, VAGINAL SECRETION, VAGINAL PH
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Internal decision of the sponsor
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Common SenseUniversity, hospital or other
- Study start
- Mar 2019 (estimated)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 2 Mar 2012 (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 NORMA-SENSE gen 3 when comes into contact with vaginal secretions having an elevated pH level
Detailed description
This study was designed to validate the color appearance on the NORMA-SENSE gen 3. The NORMA-SENSE gen 3 changes color when worn by the user and comes into contact with vaginal secretions having 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 gen 3 and the result reading clarity which includes the ability to visualize and interpret the NORMA-SENSE gen 3 results.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| color status | Experimental | Device: NORMA-SENSEThe NORMA-SENSE gen 3 polymer matrix is stained by blue or green color on a pale yellow background when the pH level of the fluid in contact with it is greater than the cutoff value, and the user can consider any stain of color, which is different from the original background, as a positive result of the test. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women, age 18 years or greater with or 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-SENSEThe NORMA-SENSE gen 3 polymer matrix is stained by blue or green color on a pale yellow background when the pH level of the fluid in contact with it is greater than the cutoff value, and the user can consider any stain of color, which is different from the original background, as a positive result of the test. | Device | color status |
Primary outcome
color status of the NORMA-SENSE gen 3 and the pH measurement.
Time frame: 3 days
agreement between the color status of the NORMA-SENSE gen 3 as reported by the subject after using the panty liners, and the pH measurement with Nitrazine paper.
1 secondary outcome
physical comfort in using NORMA-SENSE gen 3 and the result reading clarity
Time frame: 3 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2019.
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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.
Hadar Kessary, PhD study director
Common Sense
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NORMA-SENSE in people with Vaginal Infection, run by Common Sense 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: withdrawn, as of the sponsor's last update on 31 Oct 2019. 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 was withdrawn before enrolling participants, so there are no results.
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?
color status of the NORMA-SENSE gen 3 and the pH measurement. (time frame: 3 days). 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 31 Oct 2019.