Challenges of developing and executing a multi-site registry for a novel device with evolving indications for use

Jennifer L. Maranki, Steven D. Schwaitzberg, Reem Z. Sharaiha, Vladimir M. Kushnir, Dilhana S. Badurdeen, Vivek Kumbhari, Victoria Gomez, Nikhil A. Kumta, Jerome D. Waye, Jose Nieto, Michael B. Ujiki, Petros C. Benias, Larry S. Miller, Prashant Kedia, Paul Tarnasky, Abraham Mathew, John M. Levenick, Sumant Inamdar, Benjamin Tharian, Yanina NersesovaLydia Fredell, Sonya Serra, Michael L. Kochman

Research output: Contribution to journalArticlepeer-review

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™) 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.

Original languageEnglish (US)
JournalSurgical endoscopy
DOIs
StateAccepted/In press - 2022

Keywords

  • Bariatrics
  • Endoprosthetics
  • Endoscopic suturing
  • Novel technologies
  • Registry

ASJC Scopus subject areas

  • Surgery

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