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: 10708957
• 负责人: Maureen L. Mulvihill
• 金额: $ 135.47万
• 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 2025-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10708957
• 关键词: Adoption; Adult; Adverse event; Agreement; American; Certification; Cessation of life; Childhood; Clinic; Clinical; Clinical Research; Colon; Colorectal Cancer; Complex; Conduct Clinical Trials; Devices; Diagnosis; Diameter; Dissection; Distal; Effectiveness; Electrosurgery; Endoscopes; Endoscopy; Esophagus; Excision; Family suidae; Fingers; Gastrointestinal Endoscopy; Gastroscopes; Goals; Hand; Health Care Costs; Healthcare; Incidence; Institutional Review Boards; Intestines; Japanese; Learning; Legal patent; Length; Lesion; Letters; Lower Gastrointestinal Tract; Malignant - descriptor; Malignant Neoplasms; Malignant neoplasm of esophagus; Malignant neoplasm of gastrointestinal tract; Manufacturer; Medical; Medical Device; Modeling; Morbidity - disease rate; Motion; Multi-site clinical study; Operative Surgical Procedures; Outcome; Patients; Perforation; Phase; Physicians; Polypectomy; Polyps; Pre-Clinical Model; Preparation; Procedures; Public Health; Randomized; Recurrence; Recurrent tumor; Regimen; Resected; Residual state; Risk; Safety; Sales; Sessile Lesion; Site; Small Business Innovation Research Grant; Societies; Specific qualifier value; Speed; Stomach; Submucosa; Surgeon; Survival Rate; System; Techniques; Testing; Time; Tissues; Traction; Training; Universities; Visualization; Woman; acute symptom; adverse event risk; care burden; clinical research site; colorectal cancer prevention; commercialization; comparison control; cost; cost comparison; cost effective; experience; flexibility; gastrointestinal; grasp; improved; in vivo; innovation; meetings; minimally invasive; model development; operation; payment; preclinical study; programs; technological innovation; tool; tumor; verification and validation

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.

该 SBIR IIB 期项目扩展了 GripTract 产品线，包括上消化道模型 (GI) 哥伦比亚大学和克利夫兰的下消化道内窥镜检查程序和临床试验 诊所。相应二期项目中对较低 GI 模型的临床前研究表明：(a) 更少 穿孔，(b) 手术时间较短，(c) 学习曲线低于对照。 GripTract 是一个压盖 内窥镜的远端，带有连接到近端控制器的集成手指。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：可通过内窥镜检查的胃肠道癌症 - 食道、胃和肠 – 每年导致美国超过 80,000 例死亡和 $20B 的医疗费用。临床医生努力安全地 切除容易复发和恶变的大（>2 cm）、复杂的息肉（例如扁平无蒂病变）。 标准分段切除的复发率，与残余息肉和息肉风险相关 恶性病变的再种植，从 <2 cm 息肉的 3% 增加到 >2 cm 息肉的 85%。在一个日语中 研究显示，内镜粘膜下剥离术 (ESD) 能够整体切除 84-95% 的病例中的大息肉 且肿瘤复发率低至 0-2%。组织回缩困难是阻碍的一个重要因素 ESD的广泛使用。少数可用的回缩产品价格昂贵，难以使用，可能需要 特殊的内窥镜，或者可能不适用于所有胃肠道区域。 GripTract 是一款经济高效的内窥镜附件， 允许经验不足的临床医生更快地学习 ESD。这将使 ESD 得到更广泛的采用，减少 接受侵入性手术或分段切除的患者数量，并降低发病率和复发率。 IIB 期假设：整块切除具有高治愈率和低复发率。通过减少 手术时间、学习负担和不良事件 (AE) 的发生率，GripTract 将使更多 医生以更低的成本提供更好的治疗（整块切除）。目标 1：GripTract 上胃肠道 模型开发。验收标准：适合远端直径 8.9- 胃镜的上消化道模型 10.5 毫米，长度为 1030-1100 毫米。目标 2：GripTract 上部 GI 模型验证和验证 (V&V) 和 FDA 510(k) 提交。验收标准：V&V 中的所有测试均已通过。 FDA 510(k) 针对上消化道 模型。目标 3：GripTract 下胃肠道模型临床准备和离体/体内训练。验收标准： 所有为培训和临床研究而生产的设备。 IRB 提交并在 FDA 临床地点批准- 已清除较低 GI GripTract 型号。在每个站点，临床医生 (3/3) 满足培训规范（即切除 和穿孔标准），在体外和体内临床前模型中各至少进行 4 次切除 用于临床研究。目标 4：Grip-Tract 下胃肠道模型多部位随机临床研究。验收 标准：GripTract 成功演示了与安全性、解剖持续时间/速度、 和统计动力临床研究中的干净切除边缘。 GripTract 与标准 ESD 成本比较。