A Novel Radiometry‐Guided Ablation Catheter to Reliably Treat Barrett's Esophagus

一种新颖的放射测量技术——可靠地治疗巴雷特食管的引导消融导管

• 批准号: 10385615
• 负责人: Sohail Desai
• 金额: $ 39.98万
• 依托单位: SYMPLE SURGICAL, INC.
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-22 至 2023-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10385615
• 关键词: Ablation; Abnormal Cell; Address; Adopted; Adult; Affect; Africa; Algorithms; American; Asia; Barrett Epithelium; Barrett Esophagus; Cardiac ablation; Catheters; Cessation of life; Chronic; Clinical; Cold Therapy; Columnar Cell; Communication; Complication; Computer software; Devices; Disease; Distal; Epithelial; Esophageal Adenocarcinoma; Esophageal Stenosis; Esophageal Tissue; Esophagus; Excision; Exposure to; Family suidae; Feedback; Frequencies; Gastroesophageal reflux disease; Gland; Goals; Health Care Costs; Heating; Histology; Histopathology; Hospitals; Imaging technology; Incidence; Intestinal Intraepithelial Neoplasia; Intestinal Metaplasia; Intestines; Lesion; Link; Malignant Neoplasms; Malignant neoplasm of esophagus; Measurement; Modeling; Monitor; Mucous Membrane; Obesity; Operative Surgical Procedures; Outcome; Patients; Pattern; Phase; Population; Premalignant Cell; Preventive; Procedures; Radiation; Radiofrequency Interstitial Ablation; Radiometry; Recurrence; Resources; Rest; Risk; Source; Squamous Epithelium; Surface; Survival Rate; System; Technology; Temperature; Testing; Therapeutic; Thermometry; Time; Tissues; Validation; Work; base; cost; design; dosimetry; fighting; improved; in vivo; in vivo Model; innovation; microwave ablation; microwave electromagnetic radiation; minimally invasive; mortality; new technology; novel; phantom model; portability; pre-clinical; premalignant; prevent; public health relevance; radio frequency; sensor technology; success; tissue reconstruction; tool

ABSTRACT In the fight to eradicate esophageal cancer, Symple Surgical aims to develop a low-cost versatile ablation system for Barrett's esophagus (BE). BE is a serious complication of gastro-esophageal reflux disease (GERD) which affects ~40% of the US population. In more than 1.6% of people, chronic exposure to acid reflux induces BE, an esophageal epithelium abnormality that can develop into lethal esophageal adenocarcinoma (EAC). Associated with obesity, as GERD and BE, EAC is increasing in incidence more rapidly than any cancer in recent years. Current endoscopic monitoring can detect precancerous BE, which is treated usually with radiofrequency ablation (RFA), available in major hospitals. However, RFA requires multiple yearly procedures with a variety of expensive target-specific applicators. More importantly, RFA treatments ablate mostly the surface epithelium, often leaving potentially precancerous cells intact deeper in the mucosal layer. Considering the rise of deadly esophageal cancer, overcoming current overall cost and procedural challenges is thus an urgent clinical need. We thus propose to integrate reliable and versatile heating mechanism with real-time accurate thermal feedback into a novel low-cost ablation device. Our DirectAblate GRIZZLY™ Microwave Ablation Catheter technology uses a dual–purpose microwave antenna with unique advantages: i) dependable ablation zone targeting the complete mucosa; ii) real-time dosimetry and guidance by passively collecting thermal radiation from multiple sensing volumes. The immediate goal is to implement radiometric sensing in our BE microwave ablation catheter and test the system in realistic phantoms, in ex-vivo tissues and in a swine in-vivo model. The long-term objective is to significantly reduce EAC incidence by improving BE ablation reliability and accuracy with precise abnormal cell targeting and real-time thermal dosimetry. The rationale for our approach is that low-cost cutting-edge mobile communication technologies can be used for affordable microwave ablation systems with radiometric feedback. Our underlying hypothesis is that by combining innovative microwave heating and thermal sensing technologies into a single disposable catheter, we can optimally and affordably ablate BE precancerous lesions. To prove our hypothesis, we propose these specific aims: 1) Integrate multiband radiometric sensing into a versatile ablation catheter for continuous accurate control during BE ablation; 2) Test the ability to accurately feedback microwave heating in realistic phantoms, ex-vivo pig esophageal tissue and in-vivo swine. Specific milestones to prove success are: 1) Optimized integration of radiometric hardware in an endoscopic microwave ablation catheter; 2) Algorithm to reconstruct temperature at multiple depths from esophageal surface; 3) Validation of reliable heating in realistic BE phantom models for several clinical scenarios; 4) Initial assessment of ablation quality in ex-vivo and in-vivo pig esophagi. The expected outcome is a new BE ablation catheter with controllable heating pattern and real-time thermal dosimetry. We anticipate that GRIZZLY™ system will be widely adopted also in low- resource settings to remove reliably precancerous BE lesions, ultimately reducing esophageal cancer deaths.

抽象的 在根除食管癌的斗争中，Symple Surgical 旨在开发一种低成本的多功能消融系统 用于巴雷特食管 (BE)。 BE 是胃食管反流病 (GERD) 的严重并发症， 影响约 40% 的美国人口。超过 1.6% 的人长期接触胃酸反流会诱发 BE，这是一种 食管上皮异常，可发展为致命的食管腺癌（EAC）。联系 与肥胖症一样，近年来，EAC 的发病率增长速度比任何癌症都快。 目前的内窥镜监测可以检测癌前BE，通常采用射频治疗 消融术（RFA），各大医院均有提供。然而，RFA 需要每年多次进行各种程序 昂贵的特定目标涂抹器。更重要的是，RFA 治疗主要消融表面上皮， 通常会使粘膜层深处的潜在癌前细胞完好无损。考虑到致命病例的增加 因此，克服当前的总体成本和手术挑战是食管癌的迫切临床需求。 因此，我们建议将可靠且多功能的加热机制与实时准确的热反馈集成起来 成为一种新颖的低成本消融装置。我们的 DirectAblate GRIZZLY™ 微波消融导管技术 使用具有独特优势的两用微波天线：i) 可靠的消融区域，针对 完整的粘膜； ii) 通过被动收集多个热辐射进行实时剂量测定和引导 感测体积。近期目标是在我们的 BE 微波消融导管中实施辐射传感 并在真实的体模、离体组织和猪体内模型中测试该系统。长期目标 是通过提高 BE 消融的可靠性和准确性以及精确的异常来显着降低 EAC 发生率 细胞靶向和实时热剂量测定。我们的方法的基本原理是低成本的尖端移动 通信技术可用于具有辐射反馈的经济实惠的微波消融系统。 我们的基本假设是，通过结合创新的微波加热和热传感技术 通过一根一次性导管，我们可以以最佳且经济的方式消融 BE 癌前病变。来证明我们的 假设，我们提出以下具体目标：1）将多波段辐射传感集成到多功能消融中 用于 BE 消融过程中连续精确控制的导管； 2）测试微波准确反馈的能力 在真实的模型、离体猪食管组织和体内猪中加热。需要证明的具体里程碑 成功之处在于： 1) 在内窥镜微波消融导管中优化辐射测量硬件的集成； 2） 从食管表面重建多个深度温度的算法； 3) 可靠加热的验证 用于多种临床场景的真实 BE 模型； 4) 离体消融质量的初步评估 和体内猪食管。预期结果是一种具有可控加热模式的新型 BE 消融导管 和实时热剂量测定。我们预计 GRIZZLY™ 系统也将在低能耗领域得到广泛采用 资源设置以消除可靠的癌前BE病变，最终减少食管癌死亡。