Developing minimum core data structure for the obesity devices Coordinated Registry Network (CRN).


Obesity continues to be a major public health issue, with more than two-thirds of adults in the USA categorized as overweight or obese. Bariatric surgery is effective and yields durable weight loss; however, few qualified candidates choose to undergo surgical treatment. Less-invasive alternatives to bariatric surgery are being developed to bridge the treatment gap. Recognizing the burden of conducting pivotal clinical trials and traditional post-approval studies for medical devices, the Food and Drug Administration (FDA) Center for Devices and Radiological Health has encouraged the development of real-world data content and quality that is sufficient to provide evidence for Total Product Life Cycle medical device evaluation. A key first step is to establish a minimum core data structure that provides a common lexicon for endoscopic obesity devices and its corresponding interoperable data elements. Such a structure would facilitate data capture across existing workflow with a 'coordinated registry network' capability. On July 29, 2016, a workshop entitled, 'GI Coordinated Registry Network: A Case for Obesity Devices' was held at the FDA White Oak Campus by the Medical Device Epidemiology Network public-private partnership and FDA to initiate the work of developing a common lexicon and core data elements in the metabolic device space, which marked the inauguration of the Gastrointestinal Coordinated Registry Network project. Several work groups were subsequently formed to address clinical issues, data quality issues, registry participation, and data sharing.





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Publication Info

Long, Cynthia, James E Tcheng, Danica Marinac-Dabic, Andrea Iorga, Mitchell Krucoff and Deborah Fisher (2022). Developing minimum core data structure for the obesity devices Coordinated Registry Network (CRN). BMJ surgery, interventions, & health technologies, 4(Suppl 1). p. e000118. 10.1136/bmjsit-2021-000118 Retrieved from

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James Enlou Tcheng

Professor of Medicine

In addition to my clinical responsibilities as an interventional cardiologist, my research interests include the study of antithrombotic therapies in cardiovascular disease, clinical informatics, artificial intelligence, and information technology systems. 

I have conducted and participated in numerous clinical trials, including the EPIC, PROLOG, EPILOG, EPISTENT, IMPACT, IMPACT II, TOTAL, PRIDE, ESPRIT, MEND-1, ELECT, and SUPPORT Trials.

My areas of expertise are an outgrowth of my clinical research, and includes use of the new antiplatelet therapeutics in the treatment of coronary artery disease; treatment of unstable angina and acute myocardial infarction; quality assurance and quality improvement; application of informatics and information technology to the delivery of care; and the application of excimer laser coronary angioplasty in the treatment of coronary artery disease.

My current focus is in clinical informatics, including initiatives spanning professional societies, regulatory and other government agencies, industry, and non-governmental organizations to develop clinical data standards, interoperability solutions, and to integrate structured reporting into clinical workflows. This includes harmonizing the clinical definitions of cardiovascular concepts across academia, regulatory agencies, the life sciences industry, professional societies, and standards organizations, to improve the capture, communication, interoperability, and analysis of healthcare information.

Key words: angioplasty, excimer laser, platelet glycoproteins, computers, clinical trials, clinical informatics.


Mitchell Wolfe Krucoff

Professor of Medicine

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