Amniotic ProblemsPRALSNCT02959268
Pivotal Study of the Rx Al-Sense Liner for Amniotic Fluid Leakage Screening
A study testing Al-Sense in people with Amniotic Problems, run by Common Sense at 4 sites in United States.
Trial summary
This is a Prospective open-label, comparative pivotal study with comparison of self-assessments with blinded investigator assessments. Pregnant women attending the labor and delivery unit of the hospital or emergency clinic and reporting unidentified wetness (undetermined whether this is amniotic fluid leakage or… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Amniotic Problems
- What is being tested?
- Al-Sense
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 4 sitesUnited States
- Study dates
- Nov 2016to Oct 2017
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Screening/ Baseline inclusion criteria for subject participation in the study at baseline assessment are pregnant women age 18 and above who have completed minimum 16 weeks of pregnancy are eligible for the study. Subject attending the labor and delivery unit of the hospital or emergency clinic or outpatient clinic and reporting a feeling of vaginal wetness feeling (undetermined whether this is amniotic fluid leakage or urinary incontinence)
Who cannot join
None listed.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Jersey Shore University Medical Center
Neptune City, New Jersey, 07753
Rutgers Womens Health Institute
New Brunswick, New Jersey, 08901
University Hospital Rutgers Newark
Newark, New Jersey, 07103
Drexel University Medical School
Philadelphia, Pennsylvania, 19102
About this study
Official title: Pivotal Study of the Rx Al-Sense Liner for Amniotic Fluid Leakage Screening in the Second and Third Trimesters of Pregnancy
This is a Prospective open-label, comparative pivotal study with comparison of self-assessments with blinded investigator assessments. Pregnant women attending the labor and delivery unit of the hospital or emergency clinic and reporting unidentified wetness (undetermined whether this is amniotic fluid leakage or urinary incontinence) will be enrolled in this study. After informed consent is obtained, each subject will be given a single AL-SENSE to use up to 12 hours or until the perception of wetness.
Product Usage
After usage, the subject will read and record any occurrence of color change of the AL-SENSE 10 minutes after the liner removal and to mark if it changes color to blue or to green or not on the designated form. The subjects will fill out the questionnaire regarding the product usage experience and the liner color reading with no help from the investigator, to validate IFU reading comprehension. A blinded clinician will perform a "standard clinical diagnosis" (clinical assessment). The standard clinical diagnostic methods will include the following tests: (1) Pooling test, (2) Ferning test, (3) pH test by pH paper. A positive Pooling test and/or positive results in both the pH test and the Ferning test will be defined as a positive clinical test result.
Read the detailed description
This study is designed to demonstrate that the performance of the AL-SENSE developed by Common Sense Ltd. is safe and effective and can be used to indicate if the patient may be experiencing an amniotic fluid leakage .
The AL-SENSE is an extended shelf-life product that is technically simple, fast to react, visually readable, and therefore enables women to test the cause of any unidentified wetness, before confirmation by a physician.
Principles of operation:
Vaginal fluids are discharged over time and collected on the non-intrusive panty liner. If the user observes a blue or green stain, the result of the test is positive. The AL-SENSE 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.
The AL-SENSE will indicate that the pH level is elevated when the level is equal or greater than 6.5. This choice of 6.5 units as the cutoff level will limit the cases of false positive and will reduce unnecessary alarm.
Summary of Study Design
Design: Prospective open-label, comparative pivotal study with comparison of self-assessments with blinded investigator assessments.
Patient Population: Pregnant women, ages 18 and above.
Baseline/ Screening
Subjects attending the labor and delivery unit of the hospital or emergency clinic and reporting unidentified wetness (undetermined whether this is amniotic fluid leakage or urinary incontinence) will be enrolled in this study. After informed consent is obtained, each subject will be given a single AL-SENSE to use up to 12 hours or until the perception of wetness. The clinician will explain the proper use and handling of the AL-SENSE and how to read the result. The participants will be provided with instructions for use and also directed to read the Instructions For Use (IFU) prior to applying the AL-SENSE pad.
Product Usage
After usage, the subject will read and record any occurrence of color change of the AL-SENSE 10 minutes after the liner removal . The subjects will fill out the questionnaire regarding the product usage experience and the liner color reading with no help from the investigator, to validate IFU reading comprehension.
Clinical Diagnosis
A blinded clinician will perform a "standard clinical diagnosis" (clinical assessment), and record the results on a worksheet to be included in the case report form. The standard clinical diagnostic methods will include the following tests: (1) Pooling test, (2) Ferning test, (3) pH test by pH paper.
- Conditions
- Amniotic Problems
- Being tested
- Al-Sense
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Al-SenseDevice
Liner for diagnosis of amniotic fluid leakage verified by standard clinical diagnostic tests
| Study group | Role | What they receive |
|---|---|---|
| Single arm Al-Sense diagnostic | Other | Investigator blinded to subject assessments Receives: Device: Al-Sense |
What is being measured
The primary outcome is the main question the study is designed to answer.
Color change of pantyliner surface compared to standard clinical diagnosis
Color change
Measured: 10 minutes
Secondary outcomes (2)
Questionnaire to assess subject comprehension of usage criteria and subjective experience
Self-report of product usage experience and correct usage according to instructions for use
Measured: 15 minutes
Subject vs. Clinician reading of liner color change
compare subject and clinician readings
Measured: up to 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amniotic ProblemsStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Common Sense
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shantala Ramachandra, MD, Study director, Consultant Medical Monitor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02959268
- Sponsor's protocol ID
- F-7-32.4-4
- Acronym
- PRALS
- Status last verified
- Nov 2017
- First submitted
- 4 Nov 2016
- Last updated
- 31 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- 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
- Pivotal Study of the Rx Al-Sense Liner for Amniotic Fluid Leakage Screening in the Second and Third Trimesters of Pregnancy
- ClinicalTrials.gov ID
- NCT02959268
- Acronym / sponsor ID
- PRALS / F-7-32.4-4
- Conditions
- Amniotic Problems
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Common SenseUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 9 Nov 2016 (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 is a Prospective open-label, comparative pivotal study with comparison of self-assessments with blinded investigator assessments. Pregnant women attending the labor and delivery unit of the hospital or emergency clinic and reporting unidentified wetness (undetermined whether this is amniotic fluid leakage or urinary incontinence) will be enrolled in this study. After informed consent is obtained, each subject will be given a single AL-SENSE to use up to 12 hours or until the perception of wetness.
Product Usage
After usage, the subject will read and record any occurrence of color change of the AL-SENSE 10 minutes after the liner removal and to mark if it changes color to blue or to green or not on the designated form. The subjects will fill out the questionnaire regarding the product usage experience and the liner color reading with no help from the investigator, to validate IFU reading comprehension. A blinded clinician will perform a "standard clinical diagnosis" (clinical assessment). The standard clinical diagnostic methods will include the following tests: (1) Pooling test, (2) Ferning test, (3) pH test by pH paper. A positive Pooling test and/or positive results in both the pH test and the Ferning test will be defined as a positive clinical test result.
Detailed description
This study is designed to demonstrate that the performance of the AL-SENSE developed by Common Sense Ltd. is safe and effective and can be used to indicate if the patient may be experiencing an amniotic fluid leakage .
The AL-SENSE is an extended shelf-life product that is technically simple, fast to react, visually readable, and therefore enables women to test the cause of any unidentified wetness, before confirmation by a physician.
Principles of operation:
Vaginal fluids are discharged over time and collected on the non-intrusive panty liner. If the user observes a blue or green stain, the result of the test is positive. The AL-SENSE 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.
The AL-SENSE will indicate that the pH level is elevated when the level is equal or greater than 6.5. This choice of 6.5 units as the cutoff level will limit the cases of false positive and will reduce unnecessary alarm.
Summary of Study Design
Design: Prospective open-label, comparative pivotal study with comparison of self-assessments with blinded investigator assessments.
Patient Population: Pregnant women, ages 18 and above.
Baseline/ Screening
Subjects attending the labor and delivery unit of the hospital or emergency clinic and reporting unidentified wetness (undetermined whether this is amniotic fluid leakage or urinary incontinence) will be enrolled in this study. After informed consent is obtained, each subject will be given a single AL-SENSE to use up to 12 hours or until the perception of wetness. The clinician will explain the proper use and handling of the AL-SENSE and how to read the result. The participants will be provided with instructions for use and also directed to read the Instructions For Use (IFU) prior to applying the AL-SENSE pad.
Product Usage
After usage, the subject will read and record any occurrence of color change of the AL-SENSE 10 minutes after the liner removal . The subjects will fill out the questionnaire regarding the product usage experience and the liner color reading with no help from the investigator, to validate IFU reading comprehension.
Clinical Diagnosis
A blinded clinician will perform a "standard clinical diagnosis" (clinical assessment), and record the results on a worksheet to be included in the case report form. The standard clinical diagnostic methods will include the following tests: (1) Pooling test, (2) Ferning test, (3) pH test by pH paper.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm Al-Sense diagnostic | Other | Device: Al-SenseInvestigator blinded to subject assessments |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Screening/ Baseline inclusion criteria for subject participation in the study at baseline assessment are pregnant women age 18 and above who have completed minimum 16 weeks of pregnancy are eligible for the study. Subject attending the labor and delivery unit of the hospital or emergency clinic or outpatient clinic and reporting a feeling of vaginal wetness feeling (undetermined whether this is amniotic fluid leakage or urinary incontinence)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Al-SenseLiner for diagnosis of amniotic fluid leakage verified by standard clinical diagnostic tests | Device | Single arm Al-Sense diagnostic |
Primary outcome
Color change of pantyliner surface compared to standard clinical diagnosis
Time frame: 10 minutes
Color change
2 secondary outcomes
Questionnaire to assess subject comprehension of usage criteria and subjective experience
Time frame: 15 minutes
Subject vs. Clinician reading of liner color change
Time frame: up to 48 hours
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 31 Oct 2019.
- Individual participant dataSharing planned: No
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.
Shantala Ramachandra, MD study director
Consultant Medical Monitor
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Al-Sense in people with Amniotic Problems, run by Common Sense at 4 sites in United States.
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 1 inclusion and 0 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 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 4 sites in United States. 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?
Color change of pantyliner surface compared to standard clinical diagnosis (time frame: 10 minutes). 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.