@article{8b1620062aa0491c91402b3bfb6b8bcf,
title = "Challenges of developing and executing a multi-site registry for a novel device with evolving indications for use",
abstract = "Background: 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{\texttrademark}) for tissue apposition has enabled the development of applications of endoscopic suturing. Methods: 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. Results: 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. Conclusions: 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.",
keywords = "Bariatrics, Endoprosthetics, Endoscopic suturing, Novel technologies, Registry",
author = "Maranki, {Jennifer L.} and Schwaitzberg, {Steven D.} and Sharaiha, {Reem Z.} and Kushnir, {Vladimir M.} and Badurdeen, {Dilhana S.} and Vivek Kumbhari and Victoria G{\'o}mez and Kumta, {Nikhil A.} and Waye, {Jerome D.} and Jose Nieto and Ujiki, {Michael B.} and Benias, {Petros C.} and Miller, {Larry S.} and Prashant Kedia and Paul Tarnasky and Abraham Mathew and Levenick, {John M.} and Sumant Inamdar and Benjamin Tharian and Yanina Nersesova and Lydia Fredell and Sonya Serra and Kochman, {Michael L.}",
note = "Funding Information: Jennifer L. Maranki is a consultant for Boston Scientific Corp. Steven D. Schwaitzberg is a consultant with options for Human Extensions, Active Surgical, Arch Therapeutics, NuView Surgical, Levitra Magnetics, and Hai Technologies, and a <1% investor in Endolumik. Reem Z. Sharaiha is a consultant for Olympus and is both a consultant for and has received research support from Cook Medical and Boston Scientific Corp. Vladimir M. Kushnir is a consultant for Boston Scientific Corp. and Medtronic. Vivek Kumbhari is a consultant for Apollo Endosurgery, FujiFilm Medical, Boston Scientific Corp., Medtronic, and Pentax Medical, and has received research support from Apollo Endosurgery and ERBE. Victoria Gomez is a consultant for Olympus. Nikhil A. Kumta is a consultant for Apollo Endosurgery, Boston Scientific Corp., Intuitive Surgical, Olympus, and Safeheal. Michael B. Ujiki is on the scientific advisory board and has received fellowship grant funding from Boston Scientific Corp., is a consultant for Cook and Olympus, has received research grant funding and speaker honoraria from Medtronic, and is a consultant, speaker, and has received fellowship grant funding from GORE. Petros Benias has is a consultant for Fuijifilm and Apollo Endosurgery. Prashant Kedia is a consultant for Boston Scientific Corp., Olympus, and Medtronic. Abraham Mathew is a consultant for Olympus. Benjamin Tharian is a consultant for Boston Scientific Corp., Medtronic, and Olympus. Michael L. Kochman is a consultant for Olympus, Boston Scientific Corp., Medtronic, ACI, and Novella; a consultant with stock options for Virgo Systems; a consultant with stock and a limited partner with Dark Canyon Labs, and holds an equity position with Endolumik. Dilhana Badurdeen, Jerome D. Waye, Jose Nieto, Larry S. Miller, Paul Tarnasky, John M. Levenick, Sumant Inamdar, Yanina Nersesova, Lydia Fredell, and Sonya Serra have no disclosures. Publisher Copyright: {\textcopyright} 2022, The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.",
year = "2022",
month = dec,
doi = "10.1007/s00464-022-09392-7",
language = "English (US)",
volume = "36",
pages = "9123--9128",
journal = "Surgical Endoscopy",
issn = "0930-2794",
publisher = "Springer New York",
number = "12",
}