Active Disposable Cap for Endoscope Tip Stabilization and Complete Visualization and Dissection of Serrated Sessile Polyps

This SBIR Phase IIB project expands the GripTract product line to include a model for upper gastrointestinal (GI) endoscopy procedures and conducts clinical trials in the lower GI at Columbia University and Cleveland Clinic. A preclinical study of the lower GI model in the corresponding Phase II project demonstrated: (a) fewer perforations, (b) lower procedure time, and (c) lower learning curve than control. GripTract is a press-cap on the distal end of the endoscope, with integrated fingers connected to proximal controls. It allows a clinician to manipulate tissue during complex polypectomies without occupying the endoscope’s working channel. Public Health Problem: Cancers of the GI tract accessible by endoscope – esophagus, stomach, and intestines – account for > 80,000 deaths and $20B in healthcare costs in the U.S. annually. Clinicians struggle to safely resect large (>2 cm), complicated polyps (e.g., flat sessile lesions) prone to recurrence and malignancy. Recurrence rates of standard piecemeal resection, which are associated with residual polyp and risk of reseeding of malignant lesions, increase from 3% for <2 cm polyps to 85% for polyps >2 cm. In one Japanese study, endoscopic submucosal dissection (ESD) enabled en bloc removal of large polyps in 84-95% of cases and had a low 0-2% tumor recurrence rate. Difficulty retracting tissue is a significant factor impeding widespread use of ESD. The few available retraction products are expensive, difficult to use, may require a special endoscope, or may not work in all GI regions. GripTract is a cost-effective endoscopic accessory that allows less experienced clinicians to learn ESD more quickly. This will enable wider adoption of ESD, reducing the number of patients having invasive surgical or piecemeal resection, and reducing morbidity and recurrence. Phase IIB Hypothesis: En bloc resection offers high curative and low recurrence rates. By reducing the procedure time, the learning burden, and the incidence of adverse event (AEs), GripTract will enable more physicians to deliver better treatment (en bloc resection) at lower cost. Aim 1: GripTract Upper GI Model Development. Acceptance Criteria: Upper GI Model that fits gastroscopes with distal end diameters 8.9- 10.5 mm and lengths from 1030-1100 mm. Aim 2: GripTract Upper GI Model Verification and Validation (V&V) and FDA 510(k) Submission. Acceptance Criteria: All tests passed in V&V. FDA 510(k) for Upper GI model. Aim 3: GripTract Lower GI Model Clinical Preparation & Ex Vivo/In Vivo Training. Acceptance Criteria: All devices produced for training and clinical studies. IRB submission and approval at clinical sites for the FDA- cleared Lower GI GripTract models. At each site, Clinicians (3/3) meet training specifications (i.e., resection and perforation criteria) with at least 4 resections each in ex vivo and in vivo preclinical models in preparation for the clinical study. Aim 4: Grip-Tract Lower GI Model Multi-site Randomize Clinical Study. Acceptance Criteria: GripTract successfully demonstrates defined endpoints related to safety, dissection duration/speed, and clean resection margins in statistically powered clinical study. GripTract to Standard ESD cost comparison.