Guided Therapeutics provided an update regarding the start of its pivotal clinical trial. The results of this clinical study will be used to support the Company’s application for U.S. FDA approval. The clinics involved in the study represent a mix of academic and community practices as well as representative population demographics. The first of the two academic centers opened for study recruitment in April and expects enrollment and testing to commence on their next colposcopy clinic scheduled for May 5th. At the second academic center, all internal scientific and institutional review boards have approved the study and final preparations are being made to begin training there. The two community-based clinics have approved the study, signed clinical trial agreements, and are preparing to start the study. It is estimated that approximately 400 women will be tested.
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Published first on TheFly
