# Balloon Overtube Access Device for Improved Interventional Endoscopy in the Upper GI

> **NIH NIH R44** · ASPERO MEDICAL, INC. · 2024 · $1,024,810

## Abstract

PROJECT SUMMARY – 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 reduc...

## Key facts

- **NIH application ID:** 10919076
- **Project number:** 1R44DK136377-01A1
- **Recipient organization:** ASPERO MEDICAL, INC.
- **Principal Investigator:** Mark Rentschler
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $1,024,810
- **Award type:** 1
- **Project period:** 2024-07-15 → 2026-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10919076

## Citation

> US National Institutes of Health, RePORTER application 10919076, Balloon Overtube Access Device for Improved Interventional Endoscopy in the Upper GI (1R44DK136377-01A1). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10919076. Licensed CC0.

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