Non-Invasive Intraoral LED Phototherapy Device for the Prevention and Treatment of Oral Mucositis

无创口腔内LED光疗仪预防和治疗口腔粘膜炎

基本信息

批准号：
9138024
负责人：
Vedang P Kothari
金额：
$ 22.04万
依托单位：
LUMITEX, INC.
依托单位国家：
美国
项目类别：
财政年份：
2016
资助国家：
美国
起止时间：
2016-04-01 至 2017-10-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9138024
关键词：
Acceleration Address Adoption Adverse effects Affect Biocompatible Cell Death Cells Charge Clinical Clinical Data Consultations Custom Devices Diagnosis Dose Eating Engineering Environment Equipment Goals Health Care Costs Home environment Hospital Charges Infection Inflammation Lasers Lead Letters Light Low-Level Laser Therapy Malignant Neoplasms Manufacturer Name Marketing Medical Device Medical Electronics Mental Depression Methods Mucositis Mucous Membrane Oral Oral cavity Oral mucous membrane structure Outcome Output Pain Patients Penetration Pharmacologic Substance Phase Phototherapy Pilot Projects Prevention Production Radiation Radiation therapy Reporting Risk Safety Self-Administered Silicones Sleep Small Business Innovation Research Grant Social isolation Spottings Supervision Supportive care Technology Testing Therapeutic Thick Time Tissues Tonsil Toxic effect United States Variant base cancer therapy chemoradiation clinical efficacy commercial application commercialization compliance behavior cost cost effective dosage fitness flexibility head and neck cancer patient innovation irradiation meetings mortality novel oral mucositis palliative patient safety prevent public health relevance standard of care treatment duration

项目摘要

DESCRIPTION (provided by applicant): The goal of this SBIR is to create a novel phototherapeutic light delivery device which will advance the standard of care for the prevention and treatment of Oral Mucositis (OM). OM is one of the most common and highly significant toxicities of cancer therapy. Approximately 450,000 patients are affected by OM in the United States each year. OM is an extremely painful condition which breaks down the lining of the mouth and is associated with increased treatment breaks, increased 100-day mortality and a considerable increase in healthcare costs. The standard of care for patients with OM is mainly palliative, aiming to reduce pain, inflammation, and risk of infection. A new, proven, and powerful approach for both treatment and prevention of OM is Phototherapy (PT). Near-Infrared light increases the production of ATP which protects the mucosa from cell death. No reported side effects are observed from using phototherapy for the treatment of OM. Current barriers to the use of phototherapy include the cost of laser equipment, labor intensiveness, inter-operator variability, and inconsistent light penetration. Lumitex PT is developing a flexible, biocompatible silicone light guide to irradiate the entire oral mucosa with therapeutic light. The key innovation is the simultaneous irradiation of the entire oral cavity with minimal clinical supervision while significantly increasing patient comfort and compliance. Our light delivery technology can be integrated into a mouthpiece that safely delivers 4-6 J/cm2 of NIR light directly to the oral mucosa in a tolerable period of time and can demonstrate compliance. To address this hypothesis we created these aims: 1. Construction and optimization of a device utilizing light guide technology to deliver phototherapeutic light to the entire oral mucosa simultaneously. Manufacturing a device that meets the output and safety requirements detailed in this proposal will complete this aim. 2. Demonstration of patient compliance and safety in a controlled clinical environment. A pilot study will be comprised of head and neck cancer patients undergoing radiation while receiving phototherapeutic treatment under conditions mimicking expected end use. The device will be evaluated based on fitness for intended use and patient safety. Upon completion of Phase I, we will successfully have developed a phototherapeutic mouthpiece capable of delivering the required light dosage in an effective, controlled manner. During Phase II we will develop a manufacturable, sterilizable, cost-effective iteration for commercialization and prove its clinical efficacy. Our long-term goal is to create a home-based device for all patients at risk for developing Oral Mucositis, allowing the clinician to control dosage and the patient to self- administer.

描述（由申请人证明）：SBIR SBIR SBIR SBEL PHOTOTHAPEITIC LIGHT设备的目标将推进OFC的Stande，用于口服粘膜炎的症状（OM）。在美国，Hbreak降低了与医疗保健成本增加的嘴巴相关的，旨在减轻疼痛，炎症和感染风险。 OM的预防是光疗（PT）。强化，操作员间的变异性和不一致的光穿透性。关键创新。是与最小的临床临床视频相同的辐照，而显着提高患者的EFRIPENC。我们的光递送技术可以融合到可耐受的时期中，并且可以同时将光学指导光疗法触发。该提案中的详细信息将压缩AM，癌症患者将使Canceile Canceile Canceile Phototherapetic troteytictickin g the设备的使用和患者的安全性。有效的，可消毒的，用于商业化的临床效率。