权益分类	功能权益	普通用户	{{item.name}}会员
{{category.name}}	{{benefitItem.name}}

hANDY-i(TM): A non-invasive, dual-sensor handheld imager for intraoperative preservation of parathyroid glands

hANDY-i(TM)：一种非侵入性双传感器手持式成像仪，用于术中保存甲状旁腺

基本信息

批准号：
10706615
负责人：
Richard Jaepyeong Cha
金额：
$ 96.6万
依托单位：
OPTOSURGICAL, LLC
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-09-30 至 2024-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10706615
关键词：
Accidental Injury Accidents Allergic Reaction Angiography Appearance Attention Blood Vessels Brown Fat Calcium Clinical Clinical Research Clinical Trials Clinical Trials Design Color Communities Complement Complication Data Set Decision Making Detection Development Devices Diagnosis Dissection Dyes Economic Burden Endocrine Equipment Evaluation Excision Fatty acid glycerol esters Feedback Fluorescence Angiography Fluorescent Dyes Freezing Funding Gland Goals Grant Head and Neck Surgery Hospitals Hypocalcemia Hypoparathyroidism Image Imaging Device Imaging technology Indocyanine Green Injections Joints Length of Stay Light Marketing Monitor Morbidity - disease rate Neck Nerve Operating Rooms Operative Surgical Procedures Optics Otolaryngology Outcome Parathyroid gland Patients Performance Perfusion Persons Phase Plasma Play Positioning Attribute Postoperative Period Procedures Regulatory Pathway Reporting Research Research Personnel Resected Risk Risk Reduction Scientist Serum Signal Transduction Small Business Innovation Research Grant Software Engineering Standardization Sterility Stream Surgeon System Techniques Technology Thyroid Diseases Thyroid Gland Thyroid Gland Tissue Thyroidectomy Time Tissue Viability Tissues Translating Translations United States National Institutes of Health Vascular blood supply Vascularization Veterans Visual Visualization cost efficient design digital imaging ergonomics feasibility testing feeding imager imaging platform improved improved outcome lymph nodes meetings operation portability preservation prevent prototype sensor sensor technology socioeconomics thyroid neoplasm tool translational study tumor usability

项目摘要

Abstract Post-surgical hypoparathyroidism or hypocalcemia are known to occur frequently after thyroid surgeries due to the misidentification and/or accidental removal of healthy parathyroid glands. Approximately 150,000 thyroidectomies are performed in the US, 27% of these patients suffer from transient or permanent hypocalcemia, which can lead to lifelong sequelae and socioeconomic burden. Because of the small size, the variable position, and the similar appearance to the surrounding tissues such as lymph node, fat, and thyroid gland, it is often difficult for low volume surgeons to distinguish parathyroid glands from thyroid tissue. Furthermore, blood supply to parathyroid glands is fragile and can be damaged easily during dissection. This is a challenging problem because it is clinically hard to tell by visual inspection if a gland is still viable after manipulation. There are currently no standardized or practical equipment available to localize and assess viability of parathyroid glands in real time and in a non-invasive manner during operation. Thus, any viable solution would be considered as significant to the endocrine community. In this research, we propose to develop a non-invasive, handheld imager that will potentially be a paradigm changing tool for patients with thyroid tumors. Our imaging solution, called hANDY-iTM, will permit 1) a non-invasive parathyroid gland identification and 2) seamless display of tissue viability in real-time for the preservation of the parathyroid glands during thyroid surgery. This research will be a joint effort combining the technical and clinical expertise of Optosurgical, LLC and Johns Hopkins Hospital. To validate our hypothesis, we will study the following specific aims; Aim1: Clinically viable prototype development; Aim 2: Clinical trials to validate the proposed system (N=64); Aim3: Premarket device evaluation. We envision that our technology will open a new door for the digital imaging paradigm of dye-free, temporally unlimited, and precise parathyroid detection and preservation. Successful translation of this technology will potentially reduce the risk of hypoparathyroidism during thyroid surgery and improve the clinical outcomes.

摘要