Active Disposable Cap for Endoscope Tip Stabilization and Complete Visualization and Dissection of Serrated Sessile Polyps

用于内窥镜尖端稳定以及锯齿状无蒂息肉的完整可视化和解剖的主动一次性帽

• 批准号: 10324810
• 负责人: Maureen L. Mulvihill
• 金额: $ 69.45万
• 依托单位: ACTUATED MEDICAL, INC.
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-08-07 至 2022-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10324810
• 关键词: Adoption; Adult; Anatomy; Biological Models; Businesses; Caliber; Cancer Etiology; Cauterize; Cessation of life; Childhood; Colon; Colonic Polyps; Colonoscopy; Colorectal Cancer; Complex; Development; Devices; Diagnosis; Dissection; Distal; Economic Models; Effectiveness; Electrocoagulation; Endoscopes; Endoscopy; Equipment; Evaluation; Excision; Family; Family suidae; Fingers; Frequencies; Goals; Gold; Hand; Health Care Costs; Healthcare Systems; Hospitals; Human; Industrialization; Investments; Japanese Population; Legal patent; Length; Lesion; Letters; Licensing; Malignant - descriptor; Malignant Neoplasms; Manufacturer Name; Marketing; Medical; Medical Device; Medical center; Methods; Modeling; Motion; Outcome; Patient Care; Perforation; Physicians; Pilot Projects; Polypectomy; Polyps; Price; Procedures; Production; Public Health; Readiness; Recurrence; Regimen; Research Design; Residual state; Risk; Safety; Sales; Schedule; Sessile Lesion; Small Business Innovation Research Grant; Small Business Technology Transfer Research; Sterilization; System; Techniques; Technology; Testing; Time; Tissues; Traction; Update; Validation; Visualization; base; biomaterial compatibility; cancer diagnosis; care costs; colorectal cancer prevention; colorectal cancer screening; commercialization; cost; design; ergonomics; flexibility; grasp; health economics; improved; innovation; operation; patient safety; preclinical study; programs; response; safety outcomes; scale up; screening; tool; tumor; usability; validation studies; verification and validation

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).

该SBIR CRP项目开展活动，以增加医院对“Active”的获取、采用和销售