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

• 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
• 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

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（DPN）影响所有糖尿病患者的一半，而中心 对于疾病控制，美国现在有超过3700万人患有糖尿病。 大约20％的人被诊断出患有糖尿病时已经患有DPN，而DPN原因 美国每年82,000个下肢截肢。医疗保健提供者需要准确 用于检测早期DPN以改善预后的方法。 VisionQuest Biomedical已汇集了一群具有经验的科学家群体 在自动热图像分析中，糖尿病合并症诊断；和DPN的处理。 我们的目标是在获得I-Rxtherm的CRP赠款结束时获得FDA许可，我们的专利 基于糖尿病影响的神经元因素的原理，改变了 DPN患者的温度调节过程。 i-rxtherm的核心创新是它的能力 在早期阶段检测任何类型的DPN，小或大纤维，这是没有其他单身的能力 设备当前具有。 在第二阶段成功的驱动下，我们计划通过 完成文档和测试过程，使我们可以提交I-RxTherm FDA清除和。我们将通过以下特定目标来实现这些目标： AIM 1：执行软件验证和验证（V＆V）。我们将带上i-rxtherm 设计控件（符合ISO 13485）并执行软件V＆V。 AIM 2：在飞行员诊所实施I-Rxtherm。我们将进行临床研究（不是 临床试验）和在我们的大学合作者设施的主要诊所中部署I-Rxtherm 证明（1）有效的临床部署工作流以及（2）安全性和有效性。 目标3：获得监管清除。我们将与RTG和我们的监管合作伙伴合作， Pharmalex和Covelocity，以编译I类技术文件和其他文档 在第2个月和第12个月中批准以510（k）设备提交FDA。 目标4：完成市场研究并最终确定推出策略。我们将与我们的 营销顾问以我们的初步营销计划为基础。最终的营销计划将 在这些合作者的协助下，由VisionQuest员工实施。 在CRP赠款的第3个月末，我们将提交I-Rxtherm I类以进行FDA清关 然后在第12个月之前进行II级许可。