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，以包括上消化道模型 (GI)在哥伦比亚大学和克利夫兰进行下消化道的临床试验 诊所在相应的II期项目中对下GI模型进行的临床前研究表明：（a） 穿孔，（B）较短的手术时间，和（c）较低的学习曲线。GripTract是一种压盖， 内窥镜的远端，具有连接到近端控制器的集成指状物。它允许临床医生 在复杂的息肉切除术中操作组织，而不占用内窥镜的工作通道。 公共卫生问题：内窥镜可触及的胃肠道癌症-食道、胃和肠 - 每年在美国造成超过80，000人死亡和200亿美元的医疗费用。临床医生努力安全地 切除大的（>2 cm），复杂的息肉（例如，扁平无蒂病变）易于复发和恶性。 标准分段切除术的复发率，与残留息肉和 恶性病变的再种植，从3%增加到<2 cm polyps to 85% for polyps >2 cm。在一个日本 研究表明，内镜粘膜下剥离术（ESD）能够在84-95%的病例中整块切除大息肉 肿瘤复发率为0-2%。难以牵开组织是阻碍 广泛使用ESD。少数可用的牵开产品价格昂贵，难以使用，可能需要 特殊的内窥镜，或可能无法在所有GI区域工作。GripTract是一种具有成本效益的内窥镜配件， 使经验不足的临床医生能够更快地学习ESD。这将有助于更广泛地采用可持续发展教育， 进行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：整块切除术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上消化道 模型开发。验收标准：适合远端直径8.9-的胃镜的上消化道型号 10.5目标2：GripTract上消化道模型验证和确认 （V&amp;V）和FDA 510（k）提交。验收标准：上消化道的所有测试均通过V&amp;V. FDA 510（k） 模型目标3：GripTract下GI模型临床准备和离体/体内培训。验收标准： 为培训和临床研究生产的所有器械。临床试验机构向FDA提交IRB申请并获得批准- 清除下GI GripTract型号。在每个研究中心，临床医生（3/3）符合培训规范（即，切除 和穿孔标准），在制备中的离体和体内临床前模型中各进行至少4次切除 用于临床研究。目的4：Grip-Tract下消化道模型多中心随机临床研究。验收 标准：GripTract成功证明了与安全性、夹层持续时间/速度相关的定义终点， 在统计学上有把握的临床研究中，GripTract与标准ESD的成本比较。