NCT03608540

Endomina as an Aid for Endoscopic Full Thickness Resection

A Prospective Study to Evaluate the Safety and Feasibility of an Endoluminal-suturing Device (Endomina TM) as an Aid for Endoscopic Full Thickness Resection

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Erasme University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The concept of natural orifice transluminal endoscopic surgery (NOTES) (1) has evolved to endoscopic full thickness resection (EFTR). It represents innovation in technique that allows endoscopists to advance further into the endoscopic surgical space. EFTR has transformed the ability to tackle subepithelial tumors (SETs) and early mucosal neoplasm that are not amenable to classic ESD technique, enhance the staging accuracies for marginal lesions, and even increase the diagnostic capabilities for infiltrative disorders. Thus far, multiple methods have been described to perform EFTR, including nonexposed and exposed techniques, with the closure occuring before resection or after resection, respectively (2). Early comparative studies show no difference between the two methods (3). However, the procedures themselves are limited by the current tools available and by described techniques to achieve resection. Investigators are described here a novel non-exposed technique, with closure before resection, using the Endomina device.

Conditions

• Submucosal Tumor of Intestine

Interventions

Type	Name	Description
DEVICE	Endomina	Suturing system with sutures apposition then bulging then cutting

Timeline

• Start date: 2018-07-09
• Primary completion: 2021-10-25
• Completion: 2021-10-25
• First posted: 2018-08-01
• Last updated: 2021-11-24

Locations

1 site across 1 country: Belgium