Phase II year
2024
(last award dollars: 1741879574)
Phase II Amount
$1,024,810
Aspero Medical is developing an innovative, highly flexible balloon overtube access device (BOAD) to increase the adoption and safety of endoscopic submucosal dissection (ESD) and improve endoscopic mucosal resection (EMR) in the upper gastrointestinal (GI) tract. Clinically, ESD is a rapidly emerging approach that is preferred over EMR for the removal of cancerous and precancerous lesions in the upper GI (i.e., esophagus and stomach) because it offers a higher en bloc resection rate (91.7% vs. 46.7%), a higher R0 resection rate (80.3% vs. 42.3%), and a much lower recurrence rate (0.9% vs. 12.2%). Despite these advantages, longer procedure time, higher risk of perforation, and technical challenges of using the required tools leads many interventional endoscopists to choose the easier EMR technique over the superior ESD technique. This disconnect between clinical benefit and clinical practice presents an opportunity to dramatically improve patient care by increasing the adoption of a well-established, evidence-based technique through a new enabling device. In this Direct-to-Phase II SBIR, Aspero proposes to design and test the BOAD to increase the adoption of ESD, completing development through preclinical testing and design freeze, in preparation for verification and validation and ultimately submission of a 510(k) application for FDA clearance. This project builds on Aspero's prior work, which demonstrated an innovative Pillar textured balloon overtube reduces slippage during endoscopy procedures in the small bowel, increasing endoscope stability. The project also builds on Aspero's innovative C-Tube device, which is the first colonoscopy tool to incorporate an additional working channel with rotational and positional control for the use of a second tool. Adapting these innovations for use in the upper GI and combining them with integrated handle controls is expected to deliver a device that mitigates the disadvantages of ESD and increases adoption of the procedure to improve patient outcomes. AIM 1. Produce an integrated balloon and overtube shaft design with independent working channel and user-defined handle controls for upper GI use. Milestone: Deliver a device with integrated handle controls that accommodates multiple endoscope sizes, stabilizes the surgical field, incorporates a second working channel for concurrent tool use, allows for independent rotation of the overtube and endoscope, and incorporates micro-positional controls for a tool in the second working channel. AIM 2. Advance BOAD to design freeze in preparation for verification, validation, and FDA submission. Milestones: Confirm user acceptance and clinical utility of the device in an in vivo simulated use analysis. IMPACT-At completion of this project, Aspero will be positioned to then complete verification and validation testing of the BOAD through Phase IIb and/or external support, which will facilitate 510(k) submission. Real-world use is expected to reduce ESD procedure time, reduce the risk of perforations, and increase adoption by interventional endoscopists. Increased adoption of ESD is expected to reduce the recurrence rate for lesions in the upper GI, resulting in increased overall and progression-free survival.
Public Health Relevance Statement: NARRATIVE To remove cancerous tissues in the esophagus and stomach without full surgery, most doctors in the US do not use the most effective technique because it is difficult with the medical devices that are currently available. This project is intended to design and test a new device that would make this technique easier. Broad adoption of this new device is expected to improve patient outcomes including overall survival and a lower risk of cancer recurrence. Terms:
