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

Abstract In the United States approximately 500,000 hysterectomies are performed per year, typically for uterine enlargement due to fibroids. In 2014 the FDA provided guidance against uncontained laparoscopic power morcellation, a method of rapidly removing a large 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 occult 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, 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 10-20 scalpel blades and takes 20-60 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 the Claria System which enables the safe, rapid and cost-effective removal of large uteri minimally invasively. The improved surgical speed and safety the Claria System 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 IIb proposal is to submit Claria System to the FDA for De Novo clearance. Aim 1 focuses on design optimization, execution of final design verification and validation protocols to address new FDA requirements, and submission to the FDA. Aim 2 is an ex-vivo evaluation that performs a controlled comparison of the Claria System to the current gold standard ExCITE technique, specifically evaluating speed of extraction. Aim 3 addresses some final manufacturing and process validation testing to enable high volume manufacturing of the devices. As for future work, subsequent to FDA De Novo clearance, Claria will perform an additional post-market clinical evaluation, a commercial launch, and clinical studies in additional indications for benign and malignant tissue removal.