Miya Model™ Simulator: Phase II B Abstract OB/GYN Residents must develop numerous skills including pelvic exams, childbirth, open surgery, laparoscopic surgery, and vaginal surgery. Studies demonstrate that OB/GYN Residents lack training in vaginal surgical techniques, including Vaginal Hysterectomy (VH), the desired hysterectomy technique recommended by The American College of Obstetricians and Gynecologists (ACOG) because it is associated with less morbidity, quicker recovery and lower costs than abdominal hysterectomy. Furthermore, Residents do not receive adequate training in vaginal surgery techniques used to treat urinary incontinence, fecal incontinence or pelvic organ prolapse. The Miya Model™ is a complete female pelvic anatomy model designed to simulate real surgical experiences including lifelike skin and life-sized organs, realistic cutting and puncturing tensions, palpable surgical landmarks, a pressurized vascular system that bleeds when inadequate technique is used, and an inflatable bladder that can leak water if damaged. The model is modular in that all of the parts are designed as cartridges that are easily replaceable when damaged in a simulated surgery. The anatomic correctness of the model can be used to train a broad range of health professionals on general procedures like bimanual exam, speculum exam and pap smear, as well as advanced gynecologic vaginal surgeries. There is no commercially available simulator that can train vaginal surgery skills and basic gynecological procedures to a breadth of health professionals other than the Miya Model™. Phase I and II SBIR programs developed curriculua for performing VH, sling techniques for incontinence, and completed a Construct Validity study demonstrating that performance differences of novices and experts performing a VH on the Miya ModelTM were measurable. Construct Validity is a crucial step in a simulator being accepted as an assessment tool. Modifications suggested by surgeon feedback during the validation study were incorporated into a production design making the Miya Model™ and replacement cartridges more affordable while modifying the design based on surgeon feedback. Phase IIB will encompass four Specific Aims with the goal of determining if training on the Miya Model™ and its associated curricula will improve VH performance in the Operating Room (OR). This study will require assessing the baseline VH skills of Residents at six institutions, dividing the Residents into two groups for either standard or simulation training, and subsequently comparing the OR performance of both groups. When complete, the Miya Model™, curriculum, and assessment tools will be a complete training system used in OB/GYN residency programs to train vaginal surgery techniques and objectively assess surgical competency without any risk or harm to patients. It will be used in numerous and diverse residency, nursing and allied health educational programs for basic gynecology training. The Miya Model™ system will also be used by hospitals for credentialing and medical device companies for product development and training.
|Effective start/end date||9/27/16 → 8/31/23|
- National Institute of Child Health and Human Development: $997,762.00
- National Institute of Child Health and Human Development: $998,047.00
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