Thermal Imaging Modality for Detection of Large and Small Fiber Diabetic Peripheral Neuropathy

用于检测大纤维和小纤维糖尿病周围神经病变的热成像模式

基本信息

批准号：
10601546
负责人：
Peter N Soliz
金额：
$ 100.11万
依托单位：
VISIONQUEST BIOMEDICAL INC
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-09-22 至 2024-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10601546
关键词：
Affect Amputation Artificial Intelligence Biological Markers Centers for Disease Control and Prevention (U.S.)Clinic Clinical Clinical Research Clinical Trials Complications of Diabetes Mellitus Computer Assisted Computer software Consumption Detection Development Device or Instrument Development Devices Diabetes Mellitus Diagnosis Disease Documentation Early Diagnosis Early identification Environment Esthesia Feedback Fiber Funding Goals Grant Health Health Personnel Image Image Analysis Imaging Device Intervention Interview Lead Legal patent Lower Extremity Market Research Marketing Measurement Measures Medical Device Neurons Outcome Patients Peripheral Nervous System Diseases Persons Phase Physicians Physiologic Thermoregulation Primary Health Care Process Protocols documentation Readiness Reference Standards Reproducibility Risk Safety Sales Scientist Secure Sensitivity and Specificity Signal Transduction Software Validation Surveys System Temperature Testing Time United States Universities Validation Work base commercialization comorbidity design diabetic diabetic patient diagnostic tool experience foot imaging modality improved outcome innovation nerve conduction study person centered portability programs research study screening software development success tertiary care tool verification and validation vibration

项目摘要

SUMMARY Diabetic peripheral neuropathy (DPN) affects up to half of all diabetic people, and the Centers for Disease Control state that over 37 million people in the United States now live with diabetes. About 20% of people already have DPN when they are diagnosed with diabetes, and DPN causes 82,000 lower extremity amputations annually in the US. Health-care providers need an accurate means to detect early stage DPN in order to improve outcomes. VisionQuest Biomedical has assembled an interdisciplinary group of scientists with experience in automated thermal image analysis, diabetes comorbidity diagnosis; and treatment of DPN. Our goal is to have FDA clearance by the end of this CRP grant for i-RxTherm, our patented device based on the principle that neuronal factors affected by diabetes, alter the thermoregulation process in DPN patients. The core innovation of i-RxTherm is its ability to detect any type of DPN, small or large fiber, in the early stages—a capability that no other single device currently has. Driven by our Phase II success, we plan to begin the commercialization of our device by completing the documentation and testing process that will allow us to submit i-RxTherm for FDA clearance and. We will accomplish these goals through the following specific aims: Aim 1: Perform software verification and validation (V&V). We will bring i-RxTherm under design controls (compliance with ISO 13485) and perform software V&V. Aim 2: Implement i-RxTherm at pilot clinic. We will conduct a clinical research study (not a clinical trial) and deploy i-RxTherm at a primary clinic at our University collaborator’s facilities to demonstrate (1) effective clinical deployment workflow and (2) safety and efficacy. Aim 3: Gain regulatory clearance. We will work with RTG and our regulatory partners, Pharmalex and Covelocity, to compile the technical file and other documentation for Class I approval in month 2 and in the 12th month for a submission to the FDA as a 510(k) device. Aim 4: Complete market research and finalize a rollout strategy. We will work with our marketing consultants to build on our preliminary marketing plan. The final marketing plan will be implemented by VisionQuest staff with the assistance of these collaborators. By the end of Month 3 of the CRP grant, we will submit the i-RxTherm Class I for FDA clearance followed by a Class II clearance by Month 12.

概括糖尿病周围神经病变 (DPN) 影响着多达一半的糖尿病患者，而中心疾病控制中心指出，美国目前有超过 3700 万人患有糖尿病。大约 20% 的人在被诊断患有糖尿病时就已经患有 DPN，而 DPN 会导致美国每年有 82,000 例下肢截肢患者需要准确的信息。意味着检测早期 DPN 以改善结果。 VisionQuest Biomedical 组建了一支由经验丰富的跨学科科学家组成的团队自动热图像分析、糖尿病合并症诊断和 DPN 治疗。我们的目标是在本次 CRP 拨款结束时获得 FDA 批准 i-RxTherm，我们的专利该装置的原理是受糖尿病影响的神经因素会改变 i-RxTherm 的核心创新在于其能够调节 DPN 患者的体温调节过程。在早期阶段检测任何类型的 DPN（小型或大型光纤）——这是其他单一设备所不具备的能力设备当前有。在第二阶段成功的推动下，我们计划通过完成文档和测试过程，使我们能够提交 i-RxTherm FDA 批准和。我们将通过以下具体目标来实现这些目标：目标 1：执行软件验证和确认 (V&V) 我们将把 i-RxTherm 纳入其中。设计控制（符合 ISO 13485）并执行软件 V&V。目标 2：在试点诊所实施 i-RxTherm 我们将进行临床研究（不是临床研究）。临床试验）并在我们大学合作者设施的初级诊所部署 i-RxTherm 证明 (1) 有效的临床部署工作流程和 (2) 安全性和有效性。目标 3：我们将与 RTG 和我们的监管合作伙伴合作， Pharmalex 和 Covelocity，编制 I 类技术文件和其他文档在第 2 个月和第 12 个月批准作为 510(k) 设备向 FDA 提交。目标 4：完成市场研究并最终确定推出策略。营销顾问将根据我们初步的营销计划制定最终的营销计划。由 VisionQuest 员工在这些合作者的协助下实施。在 CRP 资助的第 3 个月结束时，我们将提交 i-RxTherm I 类以获得 FDA 批准随后在第 12 个月获得 II 级许可。