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PERFORMANCE STUDY OF THE AL-SENSE

NCT02965430 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 352

Last updated 2019-09-04

No results posted yet for this study

Summary

This is an open-label, comparative, and prospective pivotal study to demonstrate that AL-SENSE can indicate whether wetness sensed by pregnant women may be caused by amniotic fluid leakage rather than by urinary incontinence.

Subjects arriving at the hospital will receive a single AL-SENSE to use until they notice any wetness.

The blinded physician will perform a diagnosis according to the standard diagnostic methods (clinical assessment). The standard diagnostic methods will include the following tests: (1) Pooling test, (2) Ferning test, (3) pH test by pH paper. A positive Pooling test or positive result in both the pH test and the Ferning test is defined as a positive clinical assessment.

Conditions

  • Amniotic Problems

Interventions

DEVICE

AL-SENSE

A diagnostic pantyliner for detection of amniotic fluid leaks compared with standard clinical diagnosis

Sponsors & Collaborators

  • Common Sense

    lead OTHER

Principal Investigators

  • Liangkun Ma, MD · Peking Union Medical College Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2017-03-31
Completion
2017-04-30

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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 NCT02965430 on ClinicalTrials.gov