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A novel, simple, and dedicated device for endoscopic mucosal defect closure.

Yohei Nose1,2, Kohei Takizawa3,4, Kazuo Shiotsuki3

  • 1Department of Next Generation Endoscopic Intervention (Project ENGINE) Graduate School of Medicine Osaka University Osaka Japan.

DEN Open
|July 25, 2022
PubMed
Summary

A new device, FLEXLOOP, offers a faster and more effective method for closing mucosal defects after endoscopic submucosal dissection (ESD). This innovation addresses bleeding complications and procedural difficulties associated with current techniques.

Keywords:
device developmentendoscopic submucosal dissectionmucosal defect closure

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Area of Science:

  • Gastroenterology
  • Endoscopic Surgery
  • Medical Device Development

Background:

  • Endoscopic submucosal dissection (ESD) is a widely adopted technique for gastrointestinal lesion removal.
  • Post-procedure bleeding remains a significant complication following ESD.
  • Current methods for mucosal defect closure, such as snares and clips, are not dedicated devices and can be time-consuming and technically challenging.

Purpose of the Study:

  • To develop a novel, dedicated device for closing mucosal defects after ESD.
  • To improve upon existing methods for post-ESD defect closure.
  • To evaluate the efficacy and usability of the developed device.

Main Methods:

  • Iterative development and refinement of five prototypes for a new closure device, named FLEXLOOP.
  • Quantitative assessment of mechanical properties, including load on the stopper and thread movement during operation.
  • Evaluation of FLEXLOOP's usability and performance in porcine models, measuring operation time for defect closure compared to traditional snares.

Main Results:

  • The finalized FLEXLOOP device demonstrated improved mechanical properties, with lower sliding load and higher loosening load compared to snares.
  • Enhancements to the outer tube significantly reduced the load during sheath sliding.
  • FLEXLOOP significantly reduced the median operation time for mucosal defect closure (355 s) compared to snares (563 s) in porcine models (p=0.047).

Conclusions:

  • FLEXLOOP has been successfully developed and demonstrated feasibility for mucosal defect closure post-ESD.
  • The device offers a potentially more efficient and effective alternative to current closure methods.
  • FLEXLOOP represents a promising option for improving patient outcomes after endoscopic submucosal dissection.