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

基本信息

批准号：
9925224
负责人：
Maureen L. Mulvihill
金额：
$ 39.6万
依托单位：
ACTUATED MEDICAL, INC.
依托单位国家：
美国
项目类别：
财政年份：
2018
资助国家：
美国
起止时间：
2018-08-07 至 2022-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9925224
关键词：
Address Adverse event Awareness Cancer Etiology Cessation of life Clinical Research Colon Colonic Polyps Colonoscopy Colorectal Colorectal Cancer Complex Country Development Devices Dissection Distal Effectiveness Endoscopes Endoscopy Ensure Excision Family suidae Fingers Funding Geographic Locations Goals Grant Hand Health Care Costs Histologic Hour In Vitro Individual Influenza Japanese Population Lesion Letters Malignant Neoplasms Marketing Mechanics Medical Medical Device Modeling Motion Mucous Membrane Operative Surgical Procedures Outcome Patient Care Perforation Performance Phase Physicians Polypectomy Polyps Pre-Clinical Model Privatization Procedures Public Health Recurrence Regimen Residual state Risk Safety Sales Sessile Lesion Small Business Innovation Research Grant System Technology Testing Time Tissues Visual Visualization base cancer diagnosis care costs colorectal cancer prevention commercialization cost design experience flexibility improved in vivo innovation operation preclinical study response tool tumor verification and validation

项目摘要

The SBIR Fast-track develops, tests, and commercializes the ‘Active Disposable Cap for Endoscope (ACE) Tip Stabilization and Complete Visualization and Dissection of Serrated Sessile Polyps.’ The disposable system includes a distal-connecting cap, allowing a clinician to manipulate tissue and perform targeted aspiration during complex polypectomies using proximal controls, without occupying the endoscopic working channel. 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. Even polyps <10 mm have an estimated 29% incomplete resection rate. Larger (>2cm), complicated polyps (e.g., flat sessile lesions) are particularly prone to recurrence and malignancy, impacting patient care and healthcare costs. Rates of standard piecemeal resection, which is significantly associated with residual polyp, increases from 3% at <2cm to 85% for polyps >2cm. Endoscopic submucosal dissection (ESD) enabled en bloc removal of >2 cm polyps in 84-95% of cases, and showed a 0-2% tumor recurrence, in one Japanese study, though this expertise is limited outside this geographic region. In nearly all other countries, rates of en bloc ESD are well below 50% - and ESD procedures take over 100 minutes compared to 20-50 minutes for piecemeal resection. Open surgical resection further increases risks and costs. The goal of this proposed project is allowing a safe and effective en bloc ESD with full lesion removal to be performed rapidly. Phase I Hypothesis. ACE enables en bloc resection of large simulated polyps and acceptable forces on tissues in vitro, and demonstrates improved working capabilities in vivo with any damage to porcine colon limited to the mucosa. Aim 1 – ACE demonstrates improved polypectomy functionality and demonstrates safety from perforation in bench models. Acceptance Criteria: Favorable clinician response on ACE capabilities and performance based on 10-point Likert scale, and ≥75% (18/24) successful en bloc resections of ≥ 2cm, difficult lesions in vitro. Aim 2 – Confirm safety and efficacy feasibility of ACE in pilot preclinical study. Acceptance Criteria: Pilot in vivo study (N=3) successfully achieves simulated ≥2cm polyp removal en bloc in porcine model with no significant colon damage or adverse events at up to 72-hours post-procedure. Phase II Hypothesis. ACE is safe and effective for improving endoscopic access and stability, and complete lesion removal, during complex polypectomies in the colon. Aim 3 – Verification and validation to support regulatory submissions. Acceptance Criteria: Pass acceptance criteria on each individual test. Acceptance criteria are set on an individual test basis using a risk-based approach. Aim 4 – Demonstrate faster en bloc resection and same or better safety with ACE versus endoscope-only. Submission of the De Novo premarket application to the FDA. Acceptance Criteria: ACE reduces en bloc resection procedure time relative to endoscope-only resection (N=16; p<0.05, β<0.1) with the same or less visual and histological mucosal damage and no adverse events. FDA De Novo submission.

SBIR快速轨道开发，测试和商业化内窥镜（ACE）尖端的“主动一次性帽” 锯齿状息肉息肉的稳定和完全可视化和解剖。’一次性系统包括远端连接帽，允许临床操纵组织并进行靶向抽吸在复杂的多型切除术中，使用近端对照，而无需占据内窥镜工作通道。公共卫生问题：在美国，大肠癌是最致命，最昂贵的癌症之一。当前的内窥镜工具不足以持续完成结肠息肉。甚至息肉<10 MM的切除率估计为29％。较大（> 2厘米），复杂的息肉（例如，扁平梗病变特别容易复发和恶性肿瘤，影响患者护理和医疗保健费用。标准零切切除率与残留息肉显着相关，从3％增加息肉> 2cm的<2cm至85％。内窥镜粘膜下清扫术（ESD）启用了> 2厘米在一项日本研究中，84-95％的病例中的息肉显示，肿瘤复发0-2％，尽管这是在这个地理区域之外，专业知识受到限制。在几乎所有其他国家，整体ESD的速度很好低于50％和ESD的程序需要超过100分钟，而零碎切除术则需要20-50分钟。开放手术切除进一步增加了风险和成本。这个拟议项目的目标是安全并有效的ESD有效，以迅速进行全病变去除。第一阶段假设。 Ace启用在体外对大型模拟息肉和可接受的动力进行体外切除，并证明在体内的工作能力提高了，对猪结肠的任何损害都限制在粘膜上。目标1 - ace 证明了改善的多型切除术功能，并证明了台式模型中穿孔的安全性。接受标准：基于10分的ACE能力和性能的有利临床反应李克特量表，≥75％（18/24）成功的EN集团≥2cm，体外困难病变。目标2 - 确认ACE在临床前研究中的安全性和效率可行性。验收标准：体内试验（n = 3）在没有显着颜色的猪模型中实现了≥2厘米的≥2厘米息肉去除En Bloc 损坏或不良事件，最多72小时。 II期假设。王牌是安全有效的用于改善内窥镜的通道和稳定性，并在复杂的多型切除术中结肠。目标3 - 验证和验证以支持监管提交。接受标准：通过每个单独测试的接受标准。使用基于风险方法。 AIM 4 - 与ACE相比，请更快地进行整体切除和相同或更好的安全性仅内窥镜。提交从头市场上的申请提交给FDA。接受标准：王牌减少相对于仅内窥镜切除（n = 16; p <0.05，β<0.1）的整体切除程序时间相同或更少的视觉和组织学粘膜损伤，没有不良事件。 fda de从提交。