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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: Completed Phase 1 study of Amniotic Fluid Leakage, sponsored by Western Galilee Hospital-Nahariya.

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, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (450% higher). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 330 participants
Start Date 2006-05
Est. Completion 2006-11
Phase Phase 1

What the finished NCT00604838 record still lists

NCT00604838 is an interventional study that assigns participants to a tested intervention. The registered 330 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (450% higher).

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 a single indexed study location in 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.

How this trial's enrollment target compares

Where NCT00604838's enrollment target sits among peer trials

330 110th of 2000 higher than 1,890 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00604838, the US trial registry maintained by the National Library of Medicine. NCT00604838 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.