Faculty

Christine U. Lee, M.D., Ph.D.

Clinical Studies

Open

Sonography of the Nipple Areolar Complex (SONAC) Study Rochester, MN The purpose of this study is to determine ultrasound scanning techniques of the nipple areolar complex (NAC) that provide optimal diagnostic imaging features.

Closed for Enrollment

Use of henna to mark the skin Rochester, MN
The skin is commonly marked with an ink-based pen prior to and during ultrasound guided procedures. However, ink markings on the skin can affected by routine skip preperation. Additional limitations include its durability if the marking needs to last multiple days and its inability to write over ultrasound gel.

This is a feasibility study evaluating henna's ability to mark the skin under specified conditions, and it will not be evaluating the safety or efficacy for a medical purpose. As a result, henna is not listed in this application as a study drug or device. Henna will be applied on the human skin over ultrasound gel. Then its durability and resistence to alcohol-based antiseptic solutions containing chlorhexidine gluconate will be evaluated.

Following further discussion with ORRS, it was determined this is a feasibility study, which is not evaluating the safety or efficacy of henna for a medical purpose. Therefore an IND or IDE is not required. The IRB application has been updated accordingly.

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