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(for at least one location)
Describes the nature of a clinical study. Types include:
The primary objective of this study is to assess the difference in total fluid usage between the Fluent fluid management system and the Aquilex fluid control system.
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Open for enrollment
The purpose of this study is to investigate sociocultural influences on menstrual and uterine fibroid (UF) experiences of black women (BW) and hispanics/latinas (HL) with uterine fibroids (UF). Examining these sociocultural influences will demonstrate their impact on UF health disparities and menstrual health discussions to improve health outcomes in these two underserved and understudied populations in biomedical and women’s health research.
Uterine fibroids (UF) are a significant public health concern with a lifetime prevalence of over 70% in all women; however, Black women (BW) have been historically understudied and are disproportionately affected by UF and Hispanic/Latinas (HL) have almost been completely unstudied.
This study is being done to support a device labeling change that will allow women who have uterine fibroids and still wish to become pregnant greater access to the ExAblate treatment. In order for the Sponsor to receive permission to change the labeling, data regarding known pregnancies and their outcome are being gathered to show the known safety hazards to women who might wish to get pregnant after an ExAblate treatment
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