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NCT02959268 · ClinicalTrials.gov registry record · NA
Pivotal Study of the Rx Al-Sense Liner for Amniotic Fluid Leakage Screening
A NA study of Amniotic Problems, sponsored by Common Sense.
- Completed
- Registry status
- NA
- Development phase
- 250
- Enrollment target
- 4
- Study locations
NCT02959268 is a NA study of Amniotic Problems that has completed, run by Common Sense. The registered enrollment target is 250 participants. The trial reports 4 study locations across 2 states.
The verdict
NCT02959268, a NA study of Amniotic Problems, has completed, sponsored by Common Sense.
- COMPLETED
- Registry status
- NA
- Development phase
- 250 participants
- Enrollment target
- 4
- Study locations
Study 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 and/or positive results in both the pH test and the Ferning test will be defined as a positive clinical test result.
Conditions Studied
Interventions
- DEVICE Al-Sense
Study Locations (4)
New Jersey
- Jersey Shore University Medical Center - Neptune City
- Rutgers Womens Health Institute - New Brunswick
- University Hospital Rutgers Newark - Newark
Pennsylvania
- Drexel University Medical School - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2016-11 |
| Est. Completion | 2017-10 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02959268
The ClinicalTrials.gov registry entry for NCT02959268 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 250 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Common Sense, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Amniotic Problems appearing as the primary indexed condition, and to 1 intervention - of which Al-Sense is the first listed.
NCT02959268 reports 4 study locations spanning 2 distinct geographic areas - top geographies include New Jersey, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT02959268 about?
NCT02959268 is a clinical study titled "Pivotal Study of the Rx Al-Sense Liner for Amniotic Fluid Leakage Screening". 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 fl...
What is the current status of trial NCT02959268?
This trial is currently completed. It is a NA study. The enrollment target is 250 participants. The study started on 2016-11. Estimated completion is 2017-10.
What conditions does trial NCT02959268 study?
This clinical trial studies the following conditions: Amniotic Problems.
What interventions are being tested in trial NCT02959268?
The interventions under investigation include: Al-Sense (DEVICE).
Who is sponsoring clinical trial NCT02959268?
This trial is sponsored by Common Sense, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02959268 being conducted?
This trial has 4 study locations across New Jersey, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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