This Phase I Small Business Innovation and Research (SBIR) proposal aims to develop and validate a synthetic Soft-tissue Operative Female Training (SOFT) platform that improves training for complex and high-risk procedures in gynecology. The sedentary lifestyle of Americans is expected to increase the incidence of gynecological pathologies treated surgically, including uterine fibroids (UF), endometriosis (EM), and adenomyosis (AM). Minimally invasive and robotic-assisted surgery (MIS, RAS) are becoming popular choices of intervention for their unparalleled benefits to the patient. However, these procedures have a steep learning curve, requiring extensive surgical training. The lack of readily accessible training platforms hinders the safe acquisition and maintenance of relevant technical skills. To address this crisis, SOFT will be the first commercially available platform, providing hyper-realistic hands-on training for MIS and RAS in gynecology. Unlike current platforms, Lazarus 3D's technology utilizes soft materials with tunable mechanical properties, allowing the materials to be dissected, clamped, and stitched by the same instruments used in actual operations. This work will develop and validate a synthetic training platform for common pathologies treated with RAS. In Aim 1, Lazarus 3D will optimize synthetic polymers to mimic the biomechanics of the female reproductive system, including the uterus. These materials will behave similarly to soft tissue when operated on using RAS. Aim 2, Lazarus 3D will utilize its proprietary 3D printing technology to create the relevant female anatomy and pathologies (UF, EM, and AM). 3D models of the female reproductive system will be designed using publicly available radiological data and produced using the materials developed in aim 1. The expert surgical team at the collaborating medical institutes will provide insightful input on the realism of the anatomy and tissue properties. Aim 3, focus groups of 15 gynecologists in training from the participating institutes will assess SOFTâs validity by performing RAS procedures. The participants will determine the realism and validity of the platform using a 5-point scale Likert survey. The criteria for evaluating the realism and utility of the platform will include technical skill acquisition, confidence level, and perceived usefulness. The proposed Phase I project draws on Lazarus 3Dâs expertise in the development of accurate and realistic lifelike synthetic anatomy. We anticipate the completion of this project to provide surgeons, for the first time, with a realistic training platform that can safely accommodate all surgical procedures and steps used in RAS. The successful completion of this project will lay the groundwork for a Phase II research project, in which the SOFT platform will be validated as the standard of training and skill assessment for gynecological RAS procedures.
Public Health Relevance Statement: NARRATIVE The proposed research will develop and validate a lifelike and life-sized synthetic Soft-tissue Operative Female Training (SOFT) platform as a training tool for minimally invasive and robotic-assisted surgery (MIS, RAS) in gynecology. Studies have shown that surgeon training and skill is the biggest driver for patient safety and surgical outcomes in complex decision-making and time-sensitive scenarios. However, there is no commercially available platform that provides a realistic and risk-free environment to train gynecologists on MIS and RAS other than the SOFT platform.
Project Terms: Anatomic Sites; Anatomic structures; Anatomy; Awareness; Biomechanics; biomechanical; Cadaver; cadaveric; cadavers; Decision Making; Diathermy; Disease; Disorder; Dissection; Elasticity; endometriosis; Environment; Female; Fertility; Fecundability; Fecundity; Focus Groups; Foundations; Future; Goals; Gynecology; Health; Incidence; Learning; Maintenance; Medicine; Morbidity - disease rate; Morbidity; mortality; Oregon; Legal patent; Patents; Pathology; Patients; Pilot Projects; pilot study; Polymers; polymer; polymeric; Pregnancy; Gestation; Puncture procedure; Punctures; Radiology Specialty; General Radiology; Radiology; Recommendation; Research; Research Proposals; Risk; Robotics; Gynecologic Surgical Procedures; Gynecologic Surgery; Gynecological Surgery; Gynecological Surgical Procedure; Surveys; Survey Instrument; Family suidae; Pigs; Suidae; Swine; porcine; suid; Technology; Testing; Time; Tissues; Body Tissues; Universities; Uterine Fibroids; Fibroid Uterus; Uterine Body Fibroid; Uterine Body Leiomyoma; Uterine Corpus Fibroid; Uterine Corpus Leiomyoma; Uterine Fibroma; Uterine Leiomyoma; Uterus Fibroma; corpus uteri fibroid; corpus uteri leiomyoma; uterus leiomyoma; Uterus; womb; Vagina; Vaginal; Woman; Work; Pap smear; Pap Test; Pap screening; Papanicolaou Smear; Papanicolaou Test; Technical Expertise; technical skills; Women's Health; Female Health; Competence; Caring; Organ; improved; Procedures; Phase; Medical; Gynecologic; Ensure; Training; soft tissue; Failure; Gynecologist; R-Series Research Projects; R01 Mechanism; R01 Program; Research Grants; Research Projects; Research Project Grants; Collaborations; tool; Adenomyosis; instrument; Knowledge; Life; Adopted; Complex; 3-Dimensional; 3-D; 3D; three dimensional; Closure by clamp; Clampings; Operative Surgical Procedures; Operative Procedures; Surgical; Surgical Interventions; Surgical Procedure; surgery; interest; college; collegiate; skills training; Surgeon; American; rehearsal; Stretching; skills; Participant; empowerment; female reproductive system; Female Genital System; female reproductive body system; female reproductive organ system; gynecologic body system; gynecologic organ system; reproductive; Modeling; Property; Intervention; Intervention Strategies; interventional strategy; patient safety; reduce risk; reduce risks; reduce that risk; reduce the risk; reduce these risks; reduces risk; reduces the risk; reducing risk; reducing the risk; risk-reducing; Risk Reduction; Address; Data; Gynecologic Pathology; Patient-Focused Outcomes; Patient outcome; Patient-Centered Outcomes; patient oriented outcomes; Small Business Innovation Research Grant; SBIR; Small Business Innovation Research; Validation; validations; Development; developmental; cost; sexual functioning; Sex Functioning; 3-D modeling; 3D modeling; three-dimensional modeling; designing; design; Outcome; Prevalence; skill development; skill acquisition; comparative; prototype; aged population; population aging; aging population; high risk; minimally invasive; patient population; operations; operation; 3-D print; 3-D printer; 3D printer; 3D printing; three dimensional printing; 3D Print; Sedentary behavior; Sedentary life-style; sedentary lifestyle; improved outcome; mechanical properties; Modulus; surgical outcome; surgery outcome; preservation; safety outco
