NCT03831724

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

Definition and Validation of Normative Data of EndoFLIP™ Measurements in Healthy Subjects ("RUBY Study")

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Medtronic - MITG · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

Multicenter, Prospective, Non-Randomized clinical trial to define and validate normative data of EGJ-distensibility measurements and contractile patterns in healthy subjects. Asymptomatic subjects will be enrolled at up to 7 clinical sites in the United States. Subjects who meet inclusion and no exclusion criteria and are deemed asymptomatic will be eligible for study enrollment. The procedure visit/s will consist of the following procedures: High resolution manometry (HRM), esophagogastroduodenoscopy (EGD), endolumenal functional lumen imaging probe (EndoFLIP) and a Bravo procedure. A post procedure follow-up phone call will be conducted within 5-9 days of completing all procedures. HRM, EGD, and Bravo procedures are performed to evaluate subjects as normal in addition to being asymptomatic. Abnormal results in one or more of the procedures identifies the subject as unhealthy and the subject will be withdrawn from the study. The expected duration of subject's participation in the study is up to 70 days (up to 30 days from screening to HRM, up to 30 days to complete EGD, EndoFLIP and Bravo, plus 5-9 days for follow up call). Enrollment duration - up to 1 year

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-07-01
• Primary completion: 2020-02-01
• Completion: 2020-05-01
• First posted: 2019-02-06
• Last updated: 2019-11-19

Regulatory

• FDA-regulated device study