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Pivotal Study of the AL-SENSE in Diagnosis Amniotic Fluid Leakage

NCT03190434 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 340

Last updated 2017-06-16

No results posted yet for this study

Summary

This study is designed to demonstrate that the performance of the AL-SENSE developed by Common Sense Ltd. is safe and effective and can be used to indicate if the patient may be experiencing an amniotic fluid leakage or a "water breaking". The AL-SENSE is an extended shelf-life product that is technically simple, fast to react, visually readable, and therefore enables women to test the cause of any unidentified wetness. An additional, secondary objective is to show that the AL-SENSE is associated with levels of sensitivity and specificity that are comparable to those specified for the currently marketed AMNIOTESTTM (nitrazine yellow swabs; PRO LAB Diagnostics) product.

Conditions

  • AMNIOTIC FLUID LEAKAGE

Interventions

DEVICE

AL-SENSE

The AL-SENSE reacts differently when in contact with amniotic fluid than it does with urine. The indicator changes color to blue-green and fades back to yellow in case of urine and changes to stable blue-green in case of amniotic fluid.

Sponsors & Collaborators

  • Common Sense

    lead OTHER

Principal Investigators

  • Amanda Black, MD · Ottawa Hospital Research Institute

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

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

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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 NCT03190434 on ClinicalTrials.gov