Division of Gastroenterology and Hepatology, Department of Medicine, Penn State Hershey Medical Center, Hershey, PA, USA.
Department of Surgery, University of Buffalo, Buffalo, NY, USA.
Surg Endosc. 2022 Dec;36(12):9123-9128. doi: 10.1007/s00464-022-09392-7. Epub 2022 Aug 3.
The introduction of new technologies in endoscopy has been met with uncertainty, skepticism, and lack of standardization or training parameters, particularly when disruptive devices or techniques are involved. The widespread availability of a novel endoscopic suturing device (OverStitch™) for tissue apposition has enabled the development of applications of endoscopic suturing.
The American Gastroenterological Association partnered with Apollo Endosurgery to develop a registry to capture in a pragmatic non-randomized study the safety, effectiveness, and durability of endoscopic suturing in approximating tissue in the setting of bariatric revision and fixation of endoprosthetic devices.
We highlight the challenges of the adoption of novel techniques by examining the process of developing and executing this multicenter registry to assess real-world use of this endoscopic suturing device. We also present our preliminary data on the safety and effectiveness of the novel device as it is applied in the treatment of obesity.
The Prospective Registry for Trans-Orifice Endoscopic Suturing Applications (ES Registry) was an effective Phase 4, postmarketing registry aimed at capturing pragmatic, real-world use of a novel device. These findings serve to solidify the role of endoscopic suturing in clinical practice.
内镜新技术的引入带来了不确定性、怀疑和缺乏标准化或培训参数，特别是涉及颠覆性设备或技术时。一种新型的内镜缝合设备（OverStitch™）可用于组织贴合，这使得内镜缝合技术的应用得到了发展。
美国胃肠病学会与 Apollo Endosurgery 合作，开发了一个注册中心，旨在通过一项实用的非随机研究，在减重手术修正和内镜假体固定中，评估内镜缝合在接近组织方面的安全性、有效性和耐用性。
我们通过检查开发和执行这项多中心注册中心的过程来强调采用新技术的挑战，以评估这种新型内镜缝合设备的真实世界应用。我们还介绍了该新型设备在肥胖症治疗中的安全性和有效性的初步数据。
经口内镜下缝合应用前瞻性注册研究（ES 注册研究）是一项有效的第四阶段上市后注册研究，旨在捕捉新型设备的实际、真实世界的使用情况。这些发现有助于巩固内镜缝合在临床实践中的作用。
