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NCT00604838 · ClinicalTrials.gov registry record · Phase 1
Pivotal Study of the Al-Sense Study Protocol
A Phase 1 study of Amniotic Fluid Leakage, sponsored by Western Galilee Hospital-Nahariya.
- Completed
- Registry status
- Phase 1
- Development phase
- 330
- Enrollment target
- 2
- Study locations
NCT00604838 is a Phase 1 study of Amniotic Fluid Leakage that has completed, run by Western Galilee Hospital-Nahariya. The registered enrollment target is 330 participants. The trial reports 2 study locations across 2 states.
The verdict
NCT00604838, a Phase 1 study of Amniotic Fluid Leakage, has completed, sponsored by Western Galilee Hospital-Nahariya.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 330 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this study is to demonstrate that the Diagnostic Absorbent Panty liner (AL-SENSE Amniotic Leak Test Kit), developed by Common Sense Ltd., can distinguish between wetness sensed by pregnant women that is caused by amniotic fluid leakage and that which is caused by urinary incontinence.
Conditions Studied
Interventions
- DEVICE AL-SENSE Diagnostic Absorbent Panty liner
Study Locations (2)
Michigan
- Wayne State University / Hutzel Women's Hospital - Detroit
Other
- Western Galilee Hospital-Nahariya - Nahariya
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 330 participants |
| Start Date | 2006-05 |
| Est. Completion | 2006-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00604838
The ClinicalTrials.gov registry entry for NCT00604838 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 330 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Western Galilee Hospital-Nahariya, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Amniotic Fluid Leakage appearing as the primary indexed condition, and to 1 intervention - of which AL-SENSE Diagnostic Absorbent Panty liner is the first listed.
NCT00604838 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Michigan, Other.
Frequently Asked Questions
What is clinical trial NCT00604838 about?
NCT00604838 is a clinical study titled "Pivotal Study of the Al-Sense Study Protocol". The purpose of this study is to demonstrate that the Diagnostic Absorbent Panty liner (AL-SENSE Amniotic Leak Test Kit), developed by Common Sense Ltd., can distinguish between wetness sensed by pregnant women that is caused by amniotic fluid leakage and that which is caused by urinary incontinence.
What is the current status of trial NCT00604838?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 330 participants. The study started on 2006-05. Estimated completion is 2006-11.
What conditions does trial NCT00604838 study?
This clinical trial studies the following conditions: Amniotic Fluid Leakage.
What interventions are being tested in trial NCT00604838?
The interventions under investigation include: AL-SENSE Diagnostic Absorbent Panty liner (DEVICE).
Who is sponsoring clinical trial NCT00604838?
This trial is sponsored by Western Galilee Hospital-Nahariya, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00604838 being conducted?
This trial has 2 study locations across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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