Technical and Clinical Success of Endoscopic Hand-Suturing: A European Multicenter Study.

Area of Science:

• Gastroenterology
• Endoscopic Surgery
• Medical Devices

Background:

• Endoscopic closure techniques are crucial for managing gastrointestinal defects, preventing complications like bleeding and perforation.
• The SutuArt endoscopic hand-suturing system (EHS) offers an innovative approach to defect closure, but clinical evidence is still emerging.

Purpose of the Study:

• To evaluate the technical and clinical effectiveness of the SutuArt endoscopic hand-suturing system (EHS) in a multicenter European registry study.
• To assess the safety and success rates of EHS for various endoscopic defect closures.

Main Methods:

• A multicenter European registry study included 338 procedures using EHS across 14 centers.
• Primary endpoint: technical success (complete defect closure without additional techniques).
• Secondary endpoints: in-hospital clinical success, overall defect closure rate, and procedure time.

Main Results:

• High technical success rate of 96.2% (325/338) and overall defect closure rate of 96.7% (327/338).
• In-hospital clinical success was achieved in 97.9% (331/338) of cases.
• Low procedure-related adverse event rate of 1.5% (5/338); overall adverse events were 3% (10/338).

Conclusions:

• The endoscopic hand-suturing system (EHS) demonstrates high technical and in-hospital clinical success.
• EHS is associated with a low short-term adverse event rate, indicating its safety and efficacy.
• Further research is recommended to evaluate EHS performance in managing complex gastrointestinal defects.