In the fight to eradicate esophageal cancer, Symple Surgical aims to develop a low-cost versatile ablation systemfor Barrett's esophagus (BE). BE is a serious complication of gastro-esophageal reflux disease (GERD) whichaffects ~40% of the US population. In more than 1.6% of people, chronic exposure to acid reflux induces BE, anesophageal epithelium abnormality that can develop into lethal esophageal adenocarcinoma (EAC). Associatedwith 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 radiofrequencyablation (RFA), available in major hospitals. However, RFA requires multiple yearly procedures with a variety ofexpensive 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 deadlyesophageal 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 feedbackinto a novel low-cost ablation device. Our DirectAblate GRIZZLY⢠Microwave Ablation Catheter technologyuses a dual-purpose microwave antenna with unique advantages: i) dependable ablation zone targeting thecomplete mucosa; ii) real-time dosimetry and guidance by passively collecting thermal radiation from multiplesensing volumes. The immediate goal is to implement radiometric sensing in our BE microwave ablation catheterand test the system in realistic phantoms, in ex-vivo tissues and in a swine in-vivo model. The long-term objectiveis to significantly reduce EAC incidence by improving BE ablation reliability and accuracy with precise abnormalcell targeting and real-time thermal dosimetry. The rationale for our approach is that low-cost cutting-edge mobilecommunication 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 technologiesinto a single disposable catheter, we can optimally and affordably ablate BE precancerous lesions. To prove ourhypothesis, we propose these specific aims: 1) Integrate multiband radiometric sensing into a versatile ablationcatheter for continuous accurate control during BE ablation; 2) Test the ability to accurately feedback microwaveheating in realistic phantoms, ex-vivo pig esophageal tissue and in-vivo swine. Specific milestones to provesuccess 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 heatingin realistic BE phantom models for several clinical scenarios; 4) Initial assessment of ablation quality in ex-vivoand in-vivo pig esophagi. The expected outcome is a new BE ablation catheter with controllable heating patternand 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. PUBLIC HEALTH AND RELEVANCE STATEMENT
We propose to combine multi-frequency radiometry with microwave heating to effectively treat Barrett's disease,
thus preventing the formation of deadly esophageal adenocarcinoma. The new technology uses a disposable
and versatile micro-catheter to thermally ablate precancerous cells reliably and via a single procedure. The novel,
affordable, and accurate therapeutic tool will ultimately lower the cost of healthcare and reduce the number
esophageal cancer deaths in low-resource settings, ultimately benefiting millions of people in US and worldwide. improved ; Procedures ; Distal ; Surface ; Chronic ; Clinical ; Phase ; Link ; Lesion ; Epithelial ; Squamous Epithelium ; Columnar Cell ; Measurement ; Esophageal Adenocarcinoma ; Adenocarcinoma of the Esophagus ; Therapeutic ; Exposure to ; Abnormal Cell ; Intestinal Metaplasia ; tool ; fighting ; Adopted ; Frequencies ; Source ; Pattern ; System ; Operative Procedures ; Surgical ; Surgical Interventions ; Surgical Procedure ; surgery ; Operative Surgical Procedures ; Esophageal Cancer ; Esophagus Cancer ; Malignant Esophageal Neoplasm ; Malignant Esophageal Tumor ; Malignant Tumor of the Esophagus ; oesophageal cancer ; Malignant neoplasm of esophagus ; Ablation ; American ; phantom model ; success ; dosimetry ; Histopathology ; novel ; novel technologies ; new technology ; Devices ; Abscission ; Extirpation ; Removal ; Surgical Removal ; resection ; Excision ; RF ablation ; Radio Frequency Ablation ; Radiofrequency Ablation ; Radiofrequency Interstitial Ablation ; Radiation ; Modeling ; portability ; Barrett Epithelium ; Gland ; preventing ; prevent ; Bowel Dysplasia ; Intestinal Dysplasia ; Intestinal Intraepithelial Neoplasia ; Address ; Preventive ; precancerous ; premalignant ; Precancerous Cells ; Premalignant Cell ; in vivo ; in vivo Model ; Esophageal Tissue ; Validation ; Monitor ; pre-clinical ; preclinical ; cost ; design ; designing ; Outcome ; Imaging technology ; Population ; innovation ; innovate ; innovative ; public health relevance ; minimally invasive ; tissue reconstruction ; microwave ablation ; radio frequency ; radiofrequency ; sensor technology ; sensing technology ; Adult ; 21+ years old ; Adult Human ; adulthood ; Affect ; Africa ; Algorithms ; Asia ; Barrett Esophagus ; Barrett Syndrome ; Barrett Ulcer ; Columnar Epithelial-Lined Lower Esophagus ; Columnar-Lined Esophagus ; esophageal intestinal metaplasia ; Malignant Neoplasms ; Cancers ; Malignant Tumor ; malignancy ; neoplasm/cancer ; Communication ; Complication ; Cold Therapy ; Cryotherapy ; Therapeutic Cold ; Cessation of life ; Death ; Disease ; Disorder ; Esophageal Stenosis ; Esophageal Stricture ; Esophagus ; Feedback ; Gastroesophageal reflux disease ; Acid Reflux ; Esophageal Reflux ; GERD ; Gastro-oesophageal Reflux ; Gastroesophageal Reflux ; Goals ; Heating ; Histology ; Hospitals ; Incidence ; Intestines ; Intestinal ; bowel ; microwave electromagnetic radiation ; Microwave Electromagnetic ; Microwaves ; microwave radiation ; mortality ; Mucous Membrane ; Mucosa ; Mucosal Tissue ; Obesity ; adiposity ; corpulence ; Patients ; Radiometry ; Radiation Dosimetry ; radioassay ; Recurrence ; Recurrent ; Resources ; Research Resources ; Rest ; Risk ; Computer software ; Software ; Survival Rate ; Family suidae ; Pigs ; Suidae ; Swine ; porcine ; suid ; Technology ; Temperature ; Testing ; Time ; Tissues ; Body Tissues ; Work ; Health Care Costs ; Health Costs ; Healthcare Costs ; Catheters ; Cardiac ablation ; Catheter Ablation ; base ; Thermometry ;
