Clinical trials: Amniotic Fluid Leakage
AMNIOTIC FLUID LEAKAGE
Pivotal Study of the AL-SENSE in Diagnosis Amniotic Fluid Leakage
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…
- Trial name
- NCT03190434
- Testing
- AL-SENSE
- Volunteers
- 340 people, healthy volunteers welcome
- Sponsor
- Common Sense
Amniotic Problems
PROOF OF AMNIOSENSE BLUE IN HOME USAGE AND HOSPITAL
This is a Prospective study to demonstrate that the AMNIOSENSE Blue pad can reliably rule in or rule out amniotic fluid leak as a cause of vaginal wetness in pregnancy, thus, can be adopted by hospitals as an amniotic fluid leak…
- Trial name
- NCT03177135
- Testing
- AmnioSense
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Common Sense
Amniotic Problems
Pivotal Study of the Rx Al-Sense Liner for Amniotic Fluid Leakage Screening
This is a Prospective open-label, comparative pivotal study with comparison of self-assessments with blinded investigator assessments.
- Trial name
- PRALS (NCT02959268)
- Testing
- Al-Sense
- Where
- 4 sites in United States
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- Common Sense
Rupture of Amniotic Membranes
Analysis of ROM Plus to Detect Rupture of Membranes
Specific objectives include confirmation: i) that the ROM PLUS consistently and accurately diagnoses rupture of membranes (ROM), ii) that the technique can be understood and applied in clinical practice, and iii) that the ROM…
- Trial name
- NCT01366443
- Testing
- Sterile speculum exam, ROM Plus Exam, Chart Reveiw
- Where
- United States
- Volunteers
- 288 people, healthy volunteers welcome
- Sponsor
- Clinical Innovations, LLC
Amniotic Fluid Leakage
Study of a Diagnostic Device for Identifying Between Amniotic Fluid to Urine
The purpose of this study is to compare the reliability and validity of a new device with standard methods for diagnosing between amniotic fluid leakage due to premature rupture of the membranes (PROM) and urine.
- Trial name
- NCT01517633
- Testing
- BirthSign
- Where
- Israel
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Hadassah Medical Organization