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Gynecology Research

Study Title:  Measuring the Improvements Through the Use of the Dysis™ Colposcope and the Dysismap™ in Detecting Dysplasia of the Cervix  (IMPROVE)  (Identifier:  NCT02185599)

Study Purpose:  This study will observe and quantify shifts in colposcopy practice and outcome improvements in U.S. community-based cervical screening colposcopy examinations after the introduction of the Dysis™ Colposcope with Advanced Cervical Scan, and collect colposcopy data across multiple sites in two arms:  a prospective arm with Dysis™ being used for the examination, and a retrospective arm with data retrieved from patient charts.

Principal Investigator:  Lance Talmage, M.D.

Study Coordinator: Stephanie Smiddy, RN, CRC.  For more information, please contact 419.383.6794

Study Title:  Comparison of First Sense Breast Exam® to the University of Toledo Mammography and Biopsy Results (NCT02633605)

Study Purpose:  This study is designed to evaluate the First Sense Breast Exam® test and the analysis by Therma-Scan. The First Sense Breast Exam® test is an adjunct to a mammogram. Currently, mammography is the standard of care in screening for breast cancer, and manual thermology is an adjunctive screening method. All of the study costs will be incurred by the sponsor and the subject will incur no costs to participate in the study. The First Sense Tester is a non-significant risk device where the tester's imaging camera makes no contact with the subjects during the entire procedure.

Principal Investigator:  Haitham Elsamaloty, M.D.

Study Coordinator: Stephanie Smiddy, RN for more information, please contact 419.383.6794

Study Title:  M12-815:  A Phase 3 Study to Evaluate the Efficacy and Safety of Elagolix in Combination with Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated with Uterine Fibroids in Premenopausal Women. (NCT02654054)

Study Purpose:  This study seeks to evaluate the efficacy, safety and tolerability of elagolix alone and in combination with estradiol/norethindrone acetate for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.

Principal Investigator:  Ronica Neuhoff, M.D.

Study Coordinator: Stephanie Smiddy, RN for more information, please contact 419.383.6794


Last Updated: 7/26/16