Vaginal Tactile Imager for Pelvic Floor Biomechanical Assessment

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DESCRIPTION (provided by applicant): Pelvic organ prolapse is a highly prevalent condition affecting at least 50% of women in the US during their lifetimes. Some loss of utero-vaginal support occurs in most adult women; however, the true etiology of prolapse and differences seen among individuals is not entirely understood. Changes in the elasticity of the vaginal walls, connective support tissues and muscles are thought to be significant factors in the development of pelvic organ prolapse. We propose to develop a device entitled Vaginal Tactile Imager (VTI) for 3-D visualization and assessment of mechanical properties of pelvic floor tissues. VTI is based on the Tactile Imaging (TI) technology based on principles similar to those of manual palpation. In Phase I we designed and build 1- prototype of VTI with tactile sensor array and a motion tracking sensor, tested the training procedure with the phantoms and initiated the clinical development study with 30 patients to optimize the VTI, examination procedure, data processing algorithms and visualization approaches. Clinical results demonstrate applicability of proposed approach for 3-D imaging of the vagina and surrounding structures and characterization of normal and pelvic organ prolapse conditions. In Phase II we plan to build VTI 2-prototype, complete the bench verification studies, EMC and safety testing in the accordance with regulatory compliance to bring the device to clinical validation study with 200 patients, 2 sites, and 5 operators. The proposed device will quantitatively evaluate multiple mechanical and structural properties of vaginal walls, such as elasticity distribution, Young's modulus, elasticity contrast, size and shape of abnormal tissue, provide prolapse characterization and assess results of reconstructive surgery. The completion of proposed project promises to gain scientific knowledge, provide new technical capability and improve clinical practice in gynecology. PUBLIC HEALTH RELEVANCE: Pelvic organ prolapse is a highly prevalent condition affecting at least 50% of women in the US during their lifetimes. The goal of this project is to develop Vaginal Tactile Imager (VTI) for 3-D elasticity imaging of pelvic floor tissues and prolapse characterization that could improve pelvic floor disorder diagnosis and treatment. Our clinical data have shown that VTI has the potential to predict the risk of developing prolapse and provide insight into optimal approaches for surgical repair.