WIP 142 - Novel 4-in-1 Device Testing in a Pre-clinical Model of Neonatal Esophageal Stricture

Poster Number: WIP 142
Publication Number: WIP 142.2473

Background: Esophageal atresia is a congenital defect where the proximal and distal ends of the esophagus fail to connect. Surgical repair is complicated by postoperative anastomotic stricture, occurring in approximately 45% of cases. Current treatment involves serial balloon dilations, which require multiple anesthesia events. Infants require, on average, 4 dilations over several weeks. Steroids or other medications can be delivered during the balloon dilation in an attempt to prevent strictures from reforming. Repeated exposure to anesthesia in the neonatal period has been linked to significant neurodevelopmental impairment later in life. Currently, there is no way to avoid repeated procedures requiring anesthesia in neonates with esophageal strictures.

Objective: We aim to demonstrate feasibility of a multi-functional nasogastric tube that can perform four functions without the need for anesthesia: nutrition delivery, on demand balloon dilation at the bedside, drug delivery at the site of the stricture and esophageal effluent aspiration. Feasibility testing has demonstrated device integrity and tolerability in vivo in a rabbit pilot study. Our goal is to demonstrate reproducible device functionality and long-term use in vivo in a validated rabbit model of benign esophageal stricture.

Design/Methods: We plan to induce esophageal stricture in six New Zealand White rabbits by administering 1.5% NaOH via endoscopic mucosal injection under an approved IACUC protocol (AP-299543-0824). We will perform serial endoscopies post-injection at weeks 2, 3, and 4 to monitor for esophageal mucosal changes. When esophageal narrowing is detected, we will insert our novel 4-in-1 device and use it to dilate the stricture and to deliver tube feedings. We will also explore the impact of anti-stricture drug delivery on esophageal healing after stricture formation. Control animals will undergo endoscopy as above, but without NaOH injection or drug delivery. We have intellectual property in this device under the name Esophadex. An NIH STTR grant has been submitted to support further development.