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Sponsored by: |
Western Galilee Hospital-Nahariya |
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Information provided by: | Western Galilee Hospital-Nahariya |
ClinicalTrials.gov Identifier: | NCT00604838 |
The purpose of this study is to demonstrate that the Diagnostic Absorbent Panty liner (AL-SENSE Amniotic Leak Test Kit), developed by Common Sense Ltd., can distinguish between wetness sensed by pregnant women that is caused by amniotic fluid leakage and that which is caused by urinary incontinence.
Condition | Intervention | Phase |
---|---|---|
Amniotic Fluid Leakage |
Device: AL-SENSE Diagnostic Absorbent Panty liner |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Diagnostic, Open Label, Single Group Assignment |
Official Title: | Pivotal Study of the Al-ASense Study Protocol |
Enrollment: | 330 |
Study Start Date: | May 2006 |
Study Completion Date: | November 2006 |
Primary Completion Date: | November 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
I: Experimental |
Device: AL-SENSE Diagnostic Absorbent Panty liner
worn for 12 hours
Device: AL-SENSE Diagnostic Absorbent Panty liner
Diagnostic Absorbent Panty liner (AL-SENSE Amniotic Leak Test Kit), developed by Common Sense Ltd worn for 12 hours
|
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Michigan | |
Wayne State University / Hutzel Women's Hospital | |
Detroit, Michigan, United States, 48201 | |
Israel | |
Western Galilee Hospital-Nahariya | |
Nahariya, Israel, 22100 |
Principal Investigator: | Jacob Bornstein, MD | Western Galilee Hospital-Nahariya |
Principal Investigator: | Yoram Sorokin, MD | Wayne State University / Hutzel Women's Hospital |
Responsible Party: | Common Sense Ltd. ( Clinical studies manager ) |
Study ID Numbers: | AlSense-Pivot101 |
Study First Received: | January 17, 2008 |
Last Updated: | January 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00604838 |
Health Authority: | United States: Food and Drug Administration; Israel: Ministry of Health |
amniotic fluid leakage urinary incontinence pregnancy home test vaginal wetness |
Urinary Incontinence |