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

SBIR Fast-Track开发、测试和商业化“主动一次性内窥镜(ACE)盖”尖端 锯齿状固定多聚体的稳定化和完全可视化和解剖。一次性系统 包括远端连接帽，允许临床医生操纵组织并进行有针对性的抽吸 在使用近端控制的复杂息肉切除术中，不占用内窥镜工作通道。 公共卫生问题：在美国，结直肠癌是最致命、最昂贵的癌症之一。 目前的内窥镜检查工具不足以始终如一地完全切除结肠息肉。甚至息肉&lt；10 多发性骨髓瘤的不完全切除率估计为29%。较大(&gt；2 cm)、复杂的息肉(例如，扁平的无柄息肉 肿瘤)特别容易复发和恶性，影响患者护理和医疗保健成本。 与残留息肉显著相关的标准分段切除率从3%上升到 息肉2厘米至85%。内窥镜下黏膜下剥离术(ESD)能够整块切除&gt；2厘米 日本的一项研究显示，84-95%的病例有息肉，肿瘤复发率为0-2%。 专业知识仅限于该地理区域以外的地区。在几乎所有其他国家，整体可持续发展计划的比率都不错 低于50%-ESD程序需要100分钟以上，而零碎切除需要20-50分钟。 开放手术切除进一步增加了风险和成本。这个提议的项目的目标是允许一个安全的 和有效的整体阻断ESD，病变完全切除迅速进行。第一阶段假设。ACE支持 大型模拟息肉的整体切除和体外可接受的组织作用力，并演示了 改善了活体工作能力，对猪结肠的任何损害仅限于粘膜。目标1-ACE 展示了改进的息肉切除术功能，并在长凳模型中证明了穿孔的安全性。 验收标准：临床医生对ACE功能和性能的良好反应，以10分为基础 Likert分级，≥75%(18/24)整块切除≥2 cm，体外难以切除的病变。目标2- 在先导性临床前研究中确认血管紧张素转换酶的安全性和有效性。接受标准：体内试验性研究 (n=3)在猪模型上成功地实现了模拟≥2 cm息肉整块切除，没有明显的结肠 在术后72小时内发生损害或不良事件。第二阶段假设。ACE是安全有效的 为了在复杂的息肉切除术中改善内窥镜的通路和稳定性，并完全切除病变 冒号。目标3-验证和确认以支持监管提交。验收标准：通过 每项单项测试的验收标准。验收标准是在单个测试的基础上使用基于风险的 接近。目标4-演示使用ACE比使用ACE更快的整体切除速度和相同或更好的安全性 仅限内窥镜检查。向FDA提交De Novo上市前申请。验收标准：ACE 与仅内窥镜切除(N=16；p&lt；0.05，β&lt；0.1)相比，减少了整块切除程序的时间 视觉和组织学损伤相同或更少，无不良事件。FDA de Novo提交的材料。

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.