A Novel Endoscopic Suture Anchor ( ESA ) Device for Full‐Thickness Defect Closure: A Comprehensive Ex Vivo and In Vivo Evaluation (With Video)

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Abstract
Objectives: A novel endoscopic suture anchor (ESA) device has been developed based on the through‐the‐scope clip (TTSC) system. We conducted this preclinical study aiming to comprehensively evaluate its feasibility, safety, and efficacy for full‐thickness defect closure. Methods: Ex vivo porcine stomachs ( n = 11) and in vivo Bama porcine models ( n = 8) were used. Endoscopic full‐thickness resection (EFTR) was performed to create an artificial gastric defect, followed by defect closure using the ESA devices. The primary outcome was the closure success rate. Secondary outcomes included the technical success rate, biomechanical testing results (leakage pressure, static tensile force, and pull‐out force), closure time, complete healing rate, and incidence of adverse events (AEs). Results: In ex vivo models, both the closure and technical success rates were 90.9%, with one case of suture breakage. The mean leakage pressure, static tensile force, and pull‐out force were (20.67 ± 3.20) mmHg, (4.75 ± 0.60) N, and (9.27 ± 3.42) N, respectively. In in vivo porcine models, both the closure and technical success rates reached 100%. The mean closure time was (18.75 ± 3.99) min. Complete healing was confirmed in all animals by endoscopic and histopathological assessments at the scheduled end‐points, without AEs. Conclusion: ESA is feasible, safe, and effective for gastric full‐thickness defect closure and could be a promising device in clinical practice.

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