A Safe, Fast, and Cost-Effective System for Tissue Removal in Laparoscopic Hysterectomy and Other Minimally Invasive Surgery

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Abstract In the United States approximately 500,000 hysterectomies are performed per year, typically for uterine enlargement as a result of fibroids. In 2014 the FDA provided guidance against uncontained laparoscopic power morcellation, a method of rapidly removing a large specimen (such as the uterus) during minimally invasive surgery. The FDA determined that power morcellators increased risk of cancer spread in women undergoing laparoscopic gynecologic surgery for presumed benign fibroids. Preventing the spread of hidden cancers during minimally invasive surgery is an unaddressed need across many procedures, including: hysterectomy, myomectomy, colectomy, oophorectomy, splenectomy, and nephrectomy. The FDA guidance left gynecologic surgeons without great tools for removing large uteri minimally invasively. The primary technique developed in response to the guidance, called contained manual morcellation, is an off-label technique which requires putting the uterus in a container and extracting it with a scalpel and graspers through an incision in the abdomen or out the vagina. The technique is slow (often requires 10-30 scalpel blades and takes 20-40 minutes), and ineffective at containing cancer cells (8-41% documented container breaches). Another alternative, open surgery, is costly (~2.75 nights in the hospital) and has high associated morbidity / mortality (1:5000 mortality, 1:20 serious complications). Claria Medical is developing a Tissue Containment and Extraction System (TCES) which will enable the safe, rapid and cost-effective removal of large uteri minimally invasively. The improved surgical speed and safety that the Claria TCES provides enables surgeries to be performed in a same-day outpatient format avoiding open surgery, complications, and long hospital stays. The key milestone of this Phase II proposal is to submit the TCES to the FDA for 510(k) clearance. Aim 1 focuses on design optimization and execution of several design verification and validation protocols including: biological barrier testing, electrical safety testing, biocompatibility testing, sterilization and shelf life testing as required by the FDA. Aim 2 is a formative usability study with four surgeons and develops a surgical training protocol and validation program with surgical simulators and an animal model. Aim 3 is a summative evaluation with 34 surgeons validating the training protocol and usability of the Claria TCES during unassisted simulated uterine extraction surgery. Subsequent to FDA 510(k) clearance, ~1.5- 2 years after funding of this proposal, Claria will perform an additional post-market clinical evaluation, a commercial launch, and clinical studies in additional indications for benign and malignant tissue removal.