Healthy Subjects Clinical Trial
Official title:
Definition and Validation of Normative Data of EndoFLIP™ Measurements in Healthy Subjects ("RUBY Study")
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as unhealthy and the subject will be withdrawn from the study.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
n/a
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