Research Project
10324810
This SBIR CRP project conducts activities to increase hospital access, adoption, and sales of the ?Active Disposable Cap for Endoscope system (ACE).? ACE is a cap pressed onto the distal end of the endoscope, with integrated fingers connected to proximal controls. It allows a clinician to manipulate tissue during complex polypectomies without occupying the endoscope?s working channel. Its design enables the physician to maintain procedure ergonomics. The project goals are to: 1) optimize materials and industrial production methods to reduce overall costs, 2) produce optimized models that integrate with the majority of endoscope sizes used with differing human anatomies, and 3) conduct Verification and Validation and preclinical studies designed to confirm device equivalence for 510(k) submission. Additionally, the project team will develop an investor package, and a hospital engagement and Value Analysis Committee strategy, with business experts. Public Health Problem: In the U.S., colorectal cancer is one of the most deadly and costly forms of cancer. Current endoscopy tools are inadequate to consistently enable full resection of colon polyps. Large (>2 cm), complicated polyps (e.g., flat sessile lesions) are particularly prone to recurrence and malignancy, impacting patient care and healthcare costs. Recurrence rates of standard piecemeal resection, which are significantly associated with residual polyp and risk of reseeding of lesions if malignant, increase from 3% for <2 cm polyps to 85% for polyps >2 cm. In one Japanese study, endoscopic submucosal dissection (ESD) enabled en bloc removal of >2 cm polyps in 84-95% of cases, and demonstrated a low 0-2% tumor recurrence rate. In the U.S., the use of en bloc ESD in the colon is well below 50% frequency. ESD procedures can take over 100 minutes compared to 20-50 minutes for more commonly performed piecemeal resections, contributing to limited use of the procedure. The few systems that are available to aid traction and countertraction in ESD are expensive, complex, only fit a limited number of endoscopes, and are difficult to use one-handed. ACE will enable safe and effective en bloc ESD with full lesion removal to be performed rapidly at a wider range of facilities., the goal is to provide an ESD device to increase access and adoption of the technique in the U.S., improving efficacy, patient safety and outcomes while reducing cost. Hypothesis: By accommodating the breadth of adult human anatomies, optimization of production and scale-up and technical assistance, AMI produces a 4-model family of disposable endoscopic accessories for ESD that enable greater market access, adoption, and sales. Aim 1. ACE Models Expand Electrosurgical and Endoscope Equipment Compatibility (Mos. 1-7) Aim 2. Reduce Bill of Materials and Assembly Costs (Mos. 6-9) Aim 3. Verification and Validation (V&V) and Preclinical Study for Equivalence (Mos. 7-18) Aim 4. Business Development and Value Proposition Validation (Mos. 1-18).
