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

这个SBIR IIB阶段项目扩展了GrigTract产品线，包括一种用于上消化道的模型 (GI)内窥镜检查程序，并在哥伦比亚大学和克利夫兰的下GI进行临床试验 诊所。在相应的第二阶段项目中，对较低GI模型的临床前研究表明：(A)较少 与对照组相比，(B)手术时间更短，(C)学习曲线更短。GlipTract是一顶压力帽 内窥镜的远端，集成的手指连接到近端的控制装置。它允许临床医生 在复杂的息肉切除术中操纵组织，而不占用内窥镜的工作通道。 公共卫生问题：胃肠道癌症可通过内窥镜检查--食道、胃和肠 -占美国每年8万人死亡和200亿美元的医疗成本。临床医生努力确保安全 切除大(&gt；2厘米)、复杂的息肉(例如扁平的无梗病变)，容易复发和恶变。 标准分段切除的复发率与残留息肉和 恶性病变的重新种植，从息肉2厘米的3%增加到息肉2厘米的85%。在一个日本人中 研究表明，在84-95%的病例中，内窥镜下粘膜下剥离术(ESD)能够整块切除大息肉 肿瘤复发率低(0~2%)。组织回缩困难是阻碍 广泛使用ESD。为数不多的可收回产品价格昂贵，难以使用，可能需要 专用内窥镜，或可能不适用于所有胃肠道区域。GlipTract是一种性价比高的内窥镜配件 允许经验较少的临床医生更快地学习ESD。这将使公共服务电子化得到更广泛的采用，从而减少 接受侵入性手术或分段切除的患者数量，并减少发病率和复发。 IIB期假设：整块切除可提供高治愈率和低复发率。通过减少 流程时间、学习负担和不良事件(AES)的发生率，GlipTract将实现更多 医生以更低的成本提供更好的治疗(整体切除)。目标1：GridTract上GI 模型开发。验收标准：适合远端直径为8.9-8.9的胃镜的上GI型号 10.5毫米，长度从1030到1100毫米。目标2：GridTract上GI模型验证和验证 (V&V)和FDA 510(K)提交。验收标准：所有通过V&V的测试。FDA 510(K)针对上消化道 模特。目的3：GridTract下消化道模型临床准备及活体前/在体训练。验收标准： 为培训和临床研究而生产的所有设备。在FDA的临床现场提交和批准IRB- 已清除下GI GrigTract型号。在每个地点，临床医生(3/3)达到培训规格(即切除 和穿孔标准)，在准备中的体外和体内临床前模型中各切除至少4次 用于临床研究。目的4：GRIP-道下消化道模型多点随机临床研究。验收 标准：GlipTract成功地展示了与安全性、解剖持续时间/速度、 在统计动力的临床研究中，手术切缘清晰。GlipTract与标准ESD的成本比较。

This SBIR Phase IIB project expands the GripTract product line to include a model for upper gastrointestinal (GI) endoscopy procedures and conducts clinical trials in the lower GI at Columbia University and Cleveland Clinic. A preclinical study of the lower GI model in the corresponding Phase II project demonstrated: (a) fewer perforations, (b) lower procedure time, and (c) lower learning curve than control. GripTract is a press-cap on 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. Public Health Problem: Cancers of the GI tract accessible by endoscope – esophagus, stomach, and intestines – account for > 80,000 deaths and $20B in healthcare costs in the U.S. annually. Clinicians struggle to safely resect large (>2 cm), complicated polyps (e.g., flat sessile lesions) prone to recurrence and malignancy. Recurrence rates of standard piecemeal resection, which are associated with residual polyp and risk of reseeding of malignant lesions, 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 large polyps in 84-95% of cases and had a low 0-2% tumor recurrence rate. Difficulty retracting tissue is a significant factor impeding widespread use of ESD. The few available retraction products are expensive, difficult to use, may require a special endoscope, or may not work in all GI regions. GripTract is a cost-effective endoscopic accessory that allows less experienced clinicians to learn ESD more quickly. This will enable wider adoption of ESD, reducing the number of patients having invasive surgical or piecemeal resection, and reducing morbidity and recurrence. Phase IIB Hypothesis: En bloc resection offers high curative and low recurrence rates. By reducing the procedure time, the learning burden, and the incidence of adverse event (AEs), GripTract will enable more physicians to deliver better treatment (en bloc resection) at lower cost. Aim 1: GripTract Upper GI Model Development. Acceptance Criteria: Upper GI Model that fits gastroscopes with distal end diameters 8.9- 10.5 mm and lengths from 1030-1100 mm. Aim 2: GripTract Upper GI Model Verification and Validation (V&V) and FDA 510(k) Submission. Acceptance Criteria: All tests passed in V&V. FDA 510(k) for Upper GI model. Aim 3: GripTract Lower GI Model Clinical Preparation & Ex Vivo/In Vivo Training. Acceptance Criteria: All devices produced for training and clinical studies. IRB submission and approval at clinical sites for the FDA- cleared Lower GI GripTract models. At each site, Clinicians (3/3) meet training specifications (i.e., resection and perforation criteria) with at least 4 resections each in ex vivo and in vivo preclinical models in preparation for the clinical study. Aim 4: Grip-Tract Lower GI Model Multi-site Randomize Clinical Study. Acceptance Criteria: GripTract successfully demonstrates defined endpoints related to safety, dissection duration/speed, and clean resection margins in statistically powered clinical study. GripTract to Standard ESD cost comparison.