Shingles And Genatalia

feasibility study to test the device scalp cooling in patients with breast cancer receiving chemotherapy

A feasibility study to test the use a cooling device of the scalp that breast cancer patients will wear while undergoing chemotherapy treatment will be held at Wake Forest University Baptist Medical Center. This will be part of the first major study of medical devices in the United States.
The FDA has approved an investigational device exemption (IDE) feasibility study which took place in both Wake Forest Baptist and the University of California at San Francisco (UCSF). A total of 20 patients with breast cancer in phase one will be involved - 10 of Wake Forest Baptist and 10 at UCSF. The study will evaluate the safety and tolerability of the scalp DigniCap ™ patented cooling system that is used by patients during chemotherapy treatment to prevent hair loss. IDE The feasibility study is the first step needed to obtain FDA approval.

The cooling device of the scalp is already in clinical use throughout Europe, Canada and Japan.
Susan Melin, MD, principal investigator study, said that data from several large-scale international studies on almost 1,000 patients with chemotherapy indicates that the device is safe to use and prevents hair loss. Melin is an associate professor of Internal Medicine, Hematology and Oncology at Wake Forest Baptist who specializes in breast cancer.
"One of the first questions my patients ask is whether they will lose their hair to chemotherapy recommended for breast cancer," said Melin. "Prevention of chemotherapy-induced hair loss by using the top of scalp cooling may relieve severe psychological and emotional stress and improve quality of life for patients."

http://www.news-medical.net/news/20110225/6835/English.aspx

This device is distributed by Universal in Venezuela, ca

visit their web page for more information www.univico.com.ve