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: 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
• 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

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快速通道开发、测试和商业化“Active Disposable Cap for Endoscope（ACE）Tip” 锯齿状无蒂息肉的稳定、完整可视化和解剖。所述一次性系统 包括远端连接帽，允许临床医生操作组织并执行目标抽吸 在使用近端控制的复杂息肉切除术期间，不占用内窥镜工作通道。 公共卫生问题：在美国，结肠直肠癌是最致命和最昂贵的癌症形式之一。 目前的内窥镜检查工具不足以持续地完全切除结肠息肉。甚至息肉<10 mm估计有29%的不完全切除率。较大（>2cm）、复杂的息肉（例如，平无柄 病变）特别容易复发和恶化，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碎片切除率从3%增加到2%。 2cm<2cm to 85% for polyps >。内镜下粘膜下剥离术（ESD）能够整块切除&gt;2 cm 在日本的一项研究中，84-95%的病例中有息肉，并且显示0-2%的肿瘤复发，尽管这一研究表明， 在这一地理区域之外，专门知识有限。在几乎所有其他国家， 低于50% -ESD手术需要100分钟以上，而分段切除需要20-50分钟。 开放手术切除进一步增加了风险和成本。这个项目的目标是让一个安全的 和有效的整体ESD，并迅速进行完全病变切除。第一阶段假设。ACE使 整体切除大的模拟息肉和可接受的力量组织在体外，并证明 提高体内工作能力，对猪结肠的任何损伤均仅限于粘膜。目标1 - ACE 证实息肉切除功能得到改善，并证实在台架模型中不会发生穿孔。 验收标准：基于10分的ACE功能和性能，临床医生反应良好 Likert评分，≥75%（18/24）成功整块切除≥ 2cm的体外困难病变。目标2 - 在初步临床前研究中确认ACE的安全性和有效性可行性。验收标准：初步体内研究 （N=3）在无显著结肠的猪模型中成功实现模拟≥2cm息肉整块切除 术后72小时内的损伤或不良事件。第二阶段假设。ACE安全有效 在复杂息肉切除术中， 结肠目标3 -验证和确认以支持监管申报。验收标准：通过 每个单独测试的验收标准。使用基于风险的 approach.目标4 -证明ACE与 仅内窥镜。向FDA提交De Novo上市前申请。验收标准：ACE 与仅内镜切除术相比，减少了整块切除手术时间（N=16; p&lt;0.05，β&lt;0.1）， 相同或更少的视觉和组织学粘膜损伤，无不良事件。FDA De Novo提交。