PERFORMANCE STUDY OF THE AL-SENSE

NCT02965430 | Completed Phase 3

• 1 other identifier: F-7-32.4-5.1
• Study Type: interventional
• Target: 352
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• color change of the pantyliner in comparison to standard clinical diagnosis

  presence or absence of a blue or green stain on a yellow background as observed by the clinician yielded by the AL-SENSE in addition to the binary clinical diagnosis

  10 min

Study Arms (1)

AL-SENSE diagnostic pantyliner

EXPERIMENTAL

AL-SENSE diagnostic pantyliner of amniotic fluid compared with standard clinical diagnosis methods.

Device: AL-SENSE

Interventions

AL-SENSE DEVICE

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

AL-SENSE diagnostic pantyliner

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18 years or greater.
• Subject minimum 16 weeks of pregnancy.
• Who will sign the informed consent form.
• Who arrive at the obstetric department reporting a feeling of vaginal wetness feeling (undetermined whether this is amniotic fluid leakage or urinary incontinence).

You may not qualify if:

• Subject who has experienced intermittent vaginal bleeding between the 2nd and 3rd trimesters.
• Subjects that have had sexual intercourse within the last 12 hours.
• Subject is unable or unwilling to cooperate with study procedures.
• Subject that has been diagnosed with Bacterial Vaginosis or Trichomonas infection within the last 3 days.

Sponsors & Collaborators

• Common Sense: lead

Study Officials

• Liangkun Ma, MD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2016
• First Posted: November 16, 2016
• Study Start: November 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: April 1, 2017
• Last Updated: September 4, 2019

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share