BleedClear System: Rapid and Safe Removal of Coagulated Blood, Uncleared Fundal Pools, and Adherent Clots from the Stomach Through a 2.8 mm Endoscope Channel to Improve Efficacy in UGI Bleed Treatment

Period of Performance: 07/01/2015 - 12/31/2015


Phase 1 SBIR

Recipient Firm

Actuated Medical, Inc.
Bellefonte, PA 16823
Principal Investigator


DESCRIPTION (provided by applicant): This Phase I SBIR develops and tests feasibility of the BleedClear system to quickly clear coagulated blood that prevents effective visualization and treatment of upper gastrointestinal (UGI) bleeds. BleedClear is deployed through the 2.8 mm working channel of an endoscope, allowing the clinician to keep the endoscope in place while safely and quickly removing blood masses from the viewing area. Public Health Problem: Inpatient care for acute gastrointestinal (GI) bleeding costs the healthcare industry $2.5 billion per year. Upper GI bleeds alone result in 250,000 to 300,000 hospitalizations and 15,000 to 30,000 deaths per year in the US. UGI bleeds are generally treated with minimally invasive surgery using tools deployed through an endoscope. A well-known problem clinicians face is the presence of blood and clots that reduce endoscopic visibility and limit diagnosis and treatment of the bleeding site. Patients with uncleared fundal pools of blood, coagulated blood masses, or adherent clots suffer an increased risk of morbidity and mortality. Due to the size and quantity of the clots - often centimeters in scale - they typically clog the endoscope during attempts to aspirate them, requiring the scope to be pulled out and re-inserted multiple times in the course of a procedure. Tools employing improved suction and irrigation or graspers exist, but can still take hours of manipulation to clear clots. When visibility limits endoscopic diagnosis/treatment, i can impact length of stay, number of units of blood transfused, and lead to repeat endoscopy, interventional radiology procedures, or emergent surgery and thus straining hospital resources and driving up treatment costs. An accessory device for standard endoscopes is needed that can be deployed through the 2.8 mm working channel to quickly remove large clotted blood masses without having to remove or reposition the scope. Phase I Hypothesis: BleedClear Alpha II prototype quickly clears 3cm (diameter) x 6cm blood clots while deployed in 2.8mm working channel in UGI model, demonstrating basic feasibility of BleedClear for large clot clearance during diagnostic endoscopy for UGI bleed. Specific Aims: Aim 1: Develop BleedClear Alpha II handheld prototype and demonstrate clearing functionality while deployed in 2.8mm working channel in UGI model. Acceptance Criteria: BleedClear is successful in clearing clots when deployed through endoscope held in typical curvatures in anatomic UGI model. Feedback from clinicians (Gastroenterologists) supports overall feasibility and provide guidance to focus further development. Aim 2: Determine operating parameters for best device performance for ranging clot firmness. Acceptance Criteria: BleedClear with operating parameters demonstrating ability to completely clear porcine blood clots (6cm x 3cm in size) in <5 minutes 20/20 trials. Aim 3: Demonstrate safety of BleedClear by verifying momentary contact (<3 sec) does not puncture gastric wall. Acceptance Criteria: BleedClear prototype contacting porcine gastric wall in simulated use results in no perforations in 20/20 trials.