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

Area of Science:

• Medical device evaluation
• Public health
• Gastroenterology

Background:

• Obesity affects over two-thirds of US adults, necessitating effective weight management solutions.
• While bariatric surgery is effective, fewer eligible patients opt for it, creating a need for less-invasive alternatives.
• The FDA encourages real-world data for medical device evaluation, including Total Product Life Cycle assessment.

Purpose of the Study:

• To establish a common data structure and lexicon for endoscopic obesity devices.
• To facilitate data capture and interoperability for medical device evaluation.
• To initiate the Gastrointestinal Coordinated Registry Network project for metabolic devices.

Main Methods:

• A workshop was held at the FDA involving the Medical Device Epidemiology Network and FDA.
• Initiated the development of a common lexicon and core data elements for endoscopic obesity devices.
• Formed work groups focusing on clinical issues, data quality, registry participation, and data sharing.

Main Results:

• The Gastrointestinal Coordinated Registry Network project was inaugurated.
• A foundational step was taken towards a common data structure for obesity devices.
• Work groups were established to address key aspects of registry development and data management.

Conclusions:

• Standardizing data for endoscopic obesity devices is crucial for effective medical device evaluation.
• The coordinated registry network approach will support the Total Product Life Cycle assessment of these devices.
• Collaboration is essential for advancing the development and implementation of these data standards.