MedTrace Logo

Pivotal Study of the Al-Sense Study Protocol

NCT00604838 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2008-01-30

No results posted yet for this 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

  • Amniotic Fluid Leakage

Interventions

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

Sponsors & Collaborators

  • Western Galilee Hospital-Nahariya

    lead OTHER_GOV

Principal Investigators

  • Jacob Bornstein, MD · Western Galilee Hospital-Nahariya

  • Yoram Sorokin, MD · Wayne State University / Hutzel Women's Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2006-11-30
Completion
2006-11-30

Countries

  • United States
  • Israel

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00604838 on ClinicalTrials.gov