AgiTube (now CLR): Further Studies to Refine Device Use for the Management of Hemothorax and other Pleural Collections

In recent military engagements, thoracic injuries occurred in nearly 10% of wounded US personnel. Hemothorax (HTX), an accumulation of blood in the pleural space, is a common, life-threatening result of both military and civilian chest trauma. Traumatic HTX are typically managed by tube thoracostomy, but in many cases a measurable amount of blood remains in the chest after tube placement, a condition known as retained HTX (RH) that, if not treated, can lead to empyema ¢ an infection in the pleural space associated with a very high mortality rate. Early video assisted thoracoscopic surgery (VATS) has become a preferred primary management option for RH, but VATS requires skilled surgical specialists and supporting technology and staff ¢ resources that are not found in all settings that manage thoracic trauma. In this effort, the CLR Irrigation System (formerly AgiTube) was developed to enable thoracic irrigation via the existing chest tube and to facilitate HTX drainage / prevent RH. The CLR system was fully productized and clinically tested in a 60 patient prospective study as part of the effort. The study showed that, when compared to propensity-matched historical controls, the odds of having a secondary intervention (such as VATS) was 80% lower when the patient was irrigated with CLR vs. if not irrigated. After launching CLR at several trauma centers during the original Phase II SBIR effort, other use-cases for CLR were suggested by surgeons, including treating retained hemothorax and complicated parapneumonic effusions / empyema by combining CLR-facilitated thoracic irrigation with standard fibrinolytic therapy, as well as preventing retained hemothorax with scheduled irrigations post thoracic surgery ¢ all of which have military relevance. The objective of the proposed clinical studies is to explore key research questions that will lead to optimization of CLR-enabled thoracic irrigation (i.e., optimal timing/frequency of irrigation, size of chest tube used, combining with IPFT) for hemothorax management as well as investigate the use of CLR for managing complicated parapneumonic effusions / empyema.