Micro-textured balloons with improved traction for better control in endoscopy

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PROJECT SUMMARY Aspero Medical has developed a micro-textured balloon with reduced slippage for use with all standard endoscopes for gastrointestinal endoscopy. The currently used smooth balloons are prone to slippage that reduces the success rate of endoscopic procedures, which increases the number of procedures and contributes an estimated $100–300 million in excess costs for patients and insurers each year. In a Phase I SBIR (1R43DK126504), Aspero optimized the balloon design for performance and scalability. The company subsequently finalized manufacturing controls, completed an FDA 510(k) pre-submission meeting, and prepared a 510(k) application for FDA review. In consultation with clinical advisors, other clinicians, and key opinion leaders in the field, Aspero determined that successful adoption of the device (Aspero Ancora)—and the resulting beneficial impact on procedure success rate and patient costs—will require clinical evidence of superiority compared to well-known, established devices that are already on the market. Therefore, in this Phase II application, Aspero proposes a multi-site, randomized, double-masked clinical study to establish the superiority of Aspero Ancora vs. the Olympus ST-SB1. The study will compare procedure success rates in the middle third of the small bowel. Success rates in this portion of the bowel with current devices, including the Olympus overtube, are estimated to be about 50%. Market research indicates clinicians would consider an increase from 50% to 60% to be clinically valuable and sufficient grounds for switching to a new device. However, based on the performance of Ancora in animal studies, Aspero anticipates a success rate of at least 75%, and the proposed study is powered based on this expectation. Notably, the proposed study would be the first comparative balloon study in which the clinician is masked to the identity of the device. Aim. Demonstrate superiority of the Aspero Ancora balloon overtube compared to the Olympus ST-SB1 balloon overtube. The study will include 110 consenting patients with lesions in the middle third of the small bowel (previously confirmed by video capsule endoscopy). These individuals will be randomized to receive enteroscopy with the Ancora or ST-SB1 balloon overtube, which will be orally inserted and removed by a study assistant to mask the surgeon to the device identity. The primary outcome of interest is success in identifying the lesion, which indicates sufficient balloon control to reach and visualize the site. Superiority of the Ancora balloon overtube will be demonstrated if it achieves a success rate of 75% compared to a success rate of 50% with the Olympus ST-SB1 balloon overtube. Impact—Demonstration of superiority of Aspero Ancora is necessary for adoption by clinicians. Broad adoption is expected to improve procedure success rates, reduce time to diagnosis or treatment (thereby, improving patient outcomes), and reduce the burden and costs of care for patients, providers, and insurers.