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

NCT03831724 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2019-11-19

No results posted yet for this study

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 Abnormal results in one or more of the procedures identifies the subject as unhealthy and the subject will be withdrawn from the study.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

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 & Collaborators

  • Medtronic - MITG

    lead INDUSTRY

Principal Investigators

  • Rena Yadlapati, MD · University of Colorado, Denver

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-31
Primary Completion
2020-02-29
Completion
2020-05-31
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03831724 on ClinicalTrials.gov