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
基本信息
- 批准号:10708957
- 负责人:
- 金额:$ 135.47万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 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:
- 关键词:AdoptionAdultAdverse eventAgreementAmericanCertificationCessation of lifeChildhoodClinicClinicalClinical ResearchColonColorectal CancerComplexConduct Clinical TrialsDevicesDiagnosisDiameterDissectionDistalEffectivenessElectrosurgeryEndoscopesEndoscopyEsophagusExcisionFamily suidaeFingersGastrointestinal EndoscopyGastroscopesGoalsHandHealth Care CostsHealthcareIncidenceInstitutional Review BoardsIntestinesJapaneseLearningLegal patentLengthLesionLettersLower Gastrointestinal TractMalignant - descriptorMalignant NeoplasmsMalignant neoplasm of esophagusMalignant neoplasm of gastrointestinal tractManufacturerMedicalMedical DeviceModelingMorbidity - disease rateMotionMulti-site clinical studyOperative Surgical ProceduresOutcomePatientsPerforationPhasePhysiciansPolypectomyPolypsPre-Clinical ModelPreparationProceduresPublic HealthRandomizedRecurrenceRecurrent tumorRegimenResectedResidual stateRiskSafetySalesSessile LesionSiteSmall Business Innovation Research GrantSocietiesSpecific qualifier valueSpeedStomachSubmucosaSurgeonSurvival RateSystemTechniquesTestingTimeTissuesTractionTrainingUniversitiesVisualizationWomanacute symptomadverse event riskcare burdenclinical research sitecolorectal cancer preventioncommercializationcomparison controlcostcost comparisoncost effectiveexperienceflexibilitygastrointestinalgraspimprovedin vivoinnovationmeetingsminimally invasivemodel developmentoperationpaymentpreclinical studyprogramstechnological innovationtooltumorverification and validation
项目摘要
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.
SBIR二期ib项目扩展了GripTract产品线,包括上胃肠道模型
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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Maureen L. Mulvihill其他文献
Maureen L. Mulvihill的其他文献
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{{ truncateString('Maureen L. Mulvihill', 18)}}的其他基金
Development of an Acoustic Implant Protection System to Improve Performance and Longevity of Neural Interfaces
开发声学植入保护系统以提高神经接口的性能和寿命
- 批准号:
10552838 - 财政年份:2022
- 资助金额:
$ 135.47万 - 项目类别:
Development of an Acoustic Implant Protection System to Improve Performance and Longevity of Neural Interfaces
开发声学植入保护系统以提高神经接口的性能和寿命
- 批准号:
10763996 - 财政年份:2022
- 资助金额:
$ 135.47万 - 项目类别:
ICORPs Support for Development of an Acoustic Implant Protection System to Improve Performance and Longevity of Neural Interfaces
ICORP 支持声学植入保护系统的开发,以提高神经接口的性能和寿命
- 批准号:
10739498 - 财政年份:2022
- 资助金额:
$ 135.47万 - 项目类别:
Expansion of Engineering and Testing for 'Locally Targeted Acoustic Neuropathy Medication Delivery System for Pain Relief without Large Systemic Doses and Side Effects'
扩大“用于缓解疼痛且无大全身剂量和副作用的局部靶向听神经病药物输送系统”的工程和测试
- 批准号:
9933278 - 财政年份:2019
- 资助金额:
$ 135.47万 - 项目类别:
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:
10438928 - 财政年份:2018
- 资助金额:
$ 135.47万 - 项目类别:
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 - 财政年份:2018
- 资助金额:
$ 135.47万 - 项目类别:
Microelectrode Array Insertion System using Ultrasonic Vibration to Improve Insertion Mechanics, Reduce Tissue Dimpling and Trauma, and Improve Placement Precision in the Neocortex
使用超声波振动的微电极阵列插入系统改善插入力学,减少组织凹陷和创伤,并提高新皮质的放置精度
- 批准号:
10268984 - 财政年份:2018
- 资助金额:
$ 135.47万 - 项目类别:
Neural Implant Insertion System using Ultrasonic Vibration to Reduce Tissue Dimpling and Improve Insertion Precision of Floating Arrays in the Neocortex
使用超声波振动的神经植入物插入系统减少组织凹陷并提高新皮质中浮动阵列的插入精度
- 批准号:
9565293 - 财政年份:2018
- 资助金额:
$ 135.47万 - 项目类别:
Microelectrode Array Insertion System using Ultrasonic Vibration to Improve Insertion Mechanics, Reduce Tissue Dimpling and Trauma, and Improve Placement Precision in the Neocortex
使用超声波振动的微电极阵列插入系统改善插入力学,减少组织凹陷和创伤,并提高新皮质的放置精度
- 批准号:
10021212 - 财政年份:2018
- 资助金额:
$ 135.47万 - 项目类别:
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:
10611153 - 财政年份:2018
- 资助金额:
$ 135.47万 - 项目类别:
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