NCT00604838

Pivotal Study of the Al-Sense Study Protocol

Pivotal Study of the Al-ASense Study Protocol

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 330 (actual)
• Sponsor: Western Galilee Hospital-Nahariya · Other Government
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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

• Amniotic Fluid Leakage

Interventions

Type	Name	Description
DEVICE	AL-SENSE Diagnostic Absorbent Panty liner	worn for 12 hours
DEVICE	AL-SENSE Diagnostic Absorbent Panty liner	Diagnostic Absorbent Panty liner (AL-SENSE Amniotic Leak Test Kit), developed by Common Sense Ltd worn for 12 hours

Timeline

• Start date: 2006-05-01
• Primary completion: 2006-11-01
• Completion: 2006-11-01
• First posted: 2008-01-30
• Last updated: 2008-01-30

Locations

2 sites across 2 countries: United States, Israel