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 Abnormal results in one or more of the procedures identifies the subject as unhealthy and the subject will be withdrawn from the study.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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
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.
Define and validate normative data of esophago-gastric junction -distensibility index (EGJ-DI) measurements at 60mL in healthy subjects
Median, 25% and 75% percentile for EGJ-DI measurements at 60mL balloon fill volume
Time frame: 70 days
To define and validate normative data for an EGJ-DI at different balloon fill volumes within the same subject
Mean and median EGJ-DI at different balloon fill volumes of the same subject
Time frame: 70 days
To define and validate normative data for a maximum restrictive EGJ diameter at different balloon fill volumes within the same subject
Mean and median maximum restrictive EGJ diameter at different balloon fill volumes of the same subject
Time frame: 70 days
To define and validate normative data of a distal esophageal body diameter at different balloon fill volumes within the same subject
Mean and median distal esophageal body diameter at different balloon fill volumes of the same subject
Time frame: 70 days
To define and validate normative data of contractile patterns at different balloon fill volumes within the same subject
* Presence of Repetitive antegrade contractions (RACs) and number of antegrade contractions at different balloon fill volumes of the same subject * Presence of Repetitive Retrograde Contractions (RRCs) and number of retrograde contractions at different balloon fill volumes of the same subject
Time frame: 70 days
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