Definition and Validation of Normative Data of EndoFLIP™ Measurements in Healthy Subjects (RUBY)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03831724|
Recruitment Status : Not yet recruiting
First Posted : February 6, 2019
Last Update Posted : February 6, 2019
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 Abnormal results in one or more of the procedures identifies the subject as unhealthy and the subject will be withdrawn from the study.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
|Condition or disease||Intervention/treatment||Phase|
|Healthy Subjects||Device: EndoFLIP™ System with FLIP Topography Module||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Definition and Validation of Normative Data of EndoFLIP™ Measurements in Healthy Subjects ("RUBY Study")|
|Estimated Study Start Date :||July 2019|
|Estimated Primary Completion Date :||February 2020|
|Estimated Study Completion Date :||May 2020|
Experimental: EndoFLIP™ System
Device interventions included in this arm: HRM, EGD including biopsies, EndoFLIP and Bravo
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.
- Define and validate normative data of esophago-gastric junction -distensibility index (EGJ-DI) measurements at 60mL in healthy subjects [ Time Frame: 70 days ]Median, 25% and 75% percentile for EGJ-DI measurements at 60mL balloon fill volume
- To define and validate normative data for an EGJ-DI at different balloon fill volumes within the same subject [ Time Frame: 70 days ]Mean and median EGJ-DI at different balloon fill volumes of the same subject
- To define and validate normative data for a maximum restrictive EGJ diameter at different balloon fill volumes within the same subject [ Time Frame: 70 days ]Mean and median maximum restrictive EGJ diameter at different balloon fill volumes of the same subject
- To define and validate normative data of a distal esophageal body diameter at different balloon fill volumes within the same subject [ Time Frame: 70 days ]Mean and median distal esophageal body diameter at different balloon fill volumes of the same subject
- To define and validate normative data of contractile patterns at different balloon fill volumes within the same subject [ Time Frame: 70 days ]
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03831724
|Contact: Mirit Argov, PhDemail@example.com|
|Contact: Roni Pizem, MSc.||firstname.lastname@example.org|
|Principal Investigator:||Rena Yadlapati, MD||University of Colorado, Denver|