Definition and Validation of Normative Data of EndoFLIP™ Measurements in Healthy Subjects

NAWithdrawnINTERVENTIONAL
0
Timeline

Start Date

July 31, 2019

Primary Completion Date

February 29, 2020

Study Completion Date

May 31, 2020

Conditions
Healthy Subjects
Interventions
DEVICE

EndoFLIP™ System with FLIP Topography Module

The EndoFLIP system with the EF-322N catheter will be used. The EndoFLIP system is a tool that assesses esophageal, esophago-gastric junction (EGJ)/lower esophageal sphincter (LES), and pylorus function. It allows the measurement of LES and pylorus distensibility as well as esophageal contractile activity in response to distension. The system uses impedance planimetry to measure luminal cross-sectional area (CSA) along an axial plane during volume-controlled distention.

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Medtronic - MITG

INDUSTRY