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AL-SENSE 1-Step - Determination of Product Specificity

NCT01804348 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2013-03-05

No results posted yet for this study

Summary

Clinical diagnosis of amniotic fluid leak will be determined, according the hospital standard procedure, using pooling test and/or sterile speculum examination and /or pH test, and AmniSure, N-Dia, Inc. (immunoassay for diagnosis of ruptured fetal membranes (ROM)). Amniotic fluid leak test, using the AL- SENSE 1-Step device, will be considered positive in case of presence of a blue or green or grey stain on a yellow background of the AL-SENSE 1-Step, as observed by the patient and the clinician (positive/negative).

Conditions

  • PREMATURE RUPTURE OF MEMBRANES

Interventions

DEVICE

AL-SENSE 1-Step

a single AL-SENSE 1-Step to use up to 12 hours or until they notice any wetness.

Sponsors & Collaborators

  • Common Sense

    lead OTHER

Principal Investigators

  • Jacob Bornstain, MD · Western Galilee Hospital Nahariya, Israel

Study Design

Allocation
NA
Purpose
SCREENING
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2013-07-31
Completion
2013-08-31

Countries

  • Israel

Study Locations

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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 NCT01804348 on ClinicalTrials.gov