A Pilot Study on the Feasibility, Performance, and Safety of the ENDONEB Endoscopic Medical Device for Nebulized Application of Haemostatic Surgical Sealant After Gastrointestinal Endoscopic Resection

Aims To assess the feasibility, usability, safety, and performance of the new endoscopic device (ENDONEB) for the nebulized delivery of N-butyl-2-cyanoacrylate plus Methacryloxy-Sulfolane (NBCA-MS)-based surgical glue.

Methods This was a pre-market, pilot, single-center, prospective medical device usability and feasibility study. We prospectively enrolled patients with a clinical diagnosis of a superficial neoplastic lesion to be resected via gastrointestinal endoscopic procedures (Endoscopic Mucosal Resection [EMR] or Endoscopic Submucosal Dissection [ESD]). After resection, the ENDONEB device was used by the endoscopists. ENDONEB is a new endoscopic nebulizing device designed to facilitate the application of the CE-marked, class III NBCA-MS-based surgical glue. The device was inserted into the operative channel and NBCA-MS-based surgical glue was nebulized over the surface of the post-resection mucosal defect to create a proper sealant and hemostatic layer. The performance of the device was evaluated based on the outcomes outlined in the Clinical Investigation Plan (CIP). Study parameters were evaluated and recorded by the endoscopists who assembled the device and performed the procedure. All statistical analyses were conducted using SAS software, release 9.4.

Results Fifteen patients diagnosed with superficial neoplastic lesions and candidates for endoscopic resection (EMR or ESD) according to current clinical practice, were consecutively enrolled. All the parameters used to assess the feasibility of the technique such as the appropriateness of the ENDONEB nebulizer device for applying the surgical hemostatic-sealant (ease of use, endoscopist satisfaction/effectiveness, and correct positioning of the Investigational Medical Device [IMD] as per the user manual instructions) were rated as “Excellent” for each parameter. In each case, at least 13 out of 15 ratings were “Excellent,” with the remaining ratings being “Very good.” Additionally, the usability of the device (ability to deliver the hemostatic-sealant, ease of assembly, ability to use the IMD through the endoscope, procedure duration, ease of use, and technical complications during the application) was also predominantly rated as “Excellent.” No technical complications occurred during the procedure.

Conclusions ENDONEB demonstrated excellent usability and the overall technique was deemed easily feasible. Moreover, ENDONEB showed an excellent safety profile, with no adverse device effects or defects observed during this study

Conflicts of Interest

Authors do not have any conflict of interest to disclose.

Publication History

Article published online:
27 March 2025