Ignite Creation Date:
2024-05-06 @ 9:19 AM
Last Modification Date:
2024-10-26 @ 12:13 PM
Study NCT ID:
NCT02959268
Status:
COMPLETED
Last Update Posted:
2019-10-31
First Post:
2016-11-04
Brief Title:
Pivotal Study of the Rx Al-Sense Liner for Amniotic Fluid Leakage Screening
Sponsor:
Common Sense
Organization:
Common Sense
Study Overview
Official Title:
Pivotal Study of the Rx Al-Sense Liner for Amniotic Fluid Leakage Screening in the Second and Third Trimesters of Pregnancy
Status:
COMPLETED
Status Verified Date:
2017-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRALS
Brief 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 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 andor positive results in both the pH test and the Ferning test will be defined as a positive clinical test result
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 andor 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 65 This choice of 65 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
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 65 This choice of 65 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None