EndoFLIP Use in Upper GI Tract Stenosis (EndoFLIP)
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|ClinicalTrials.gov Identifier: NCT02354716|
Recruitment Status : Recruiting
First Posted : February 3, 2015
Last Update Posted : February 19, 2018
|Condition or disease||Intervention/treatment|
|Esophageal Stricture Eosinophilic Esophagitis Zenkers Diverticulum Schatzki Ring||Device: EndoFLIP|
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Expanding the Clinical Applications of Functional Luminal Imaging (EndoFLIP) in Esophageal Stenoses|
|Study Start Date :||December 2014|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2019|
To define the role of a functional luminal imaging probe (EndoFLIP) in benign upper GI luminal narrowing. EndoFlip measurement of the cross sectional area of the narrowing will be obtained prior to and after endoscopic dilation. Patients will follow up for repeat endoscopy and dilation if indicated. EndoFLIP measurements will be made again before and after dilation. The use of EndoFlip may offer insight in to the clinical and endoscopic predictors of successful stricture dilation.
The Endolumenal Functional Lumenal Imaging Probe Imaging System is a technology developed to measure the dimensions & function of a variety of hollow organs throughout the body. Since receiving FDA clearance for sale in the United States EndoFLIP has been used in a variety of clinical applications. We intend to investigate the potential clinical applications of EndoFLIP in the upper GI tract in patients with esophageal stenoses who require endoscopic therapy for benign esophageal strictures. The use of EndoFLIP to characterize a stricture pre- & post- dilation may offer insight in to the clinical and endoscopic predictors of successful stricture dilation, & what characteristics determine & predict refractory & recurrent strictures.
Other Name: Endolumenal Functional Lumenal Imaging Probe
- Collection of Measurements of the Luminal Narrowing Using EndoFlip [ Time Frame: 12 Months ]The study is observational and a proof of concept study. Measurements of the luminal narrowing using EndoFLIP will be obtained.
- Observation of Pre-Endoscopic Therapy EndoFLIP Measurements [ Time Frame: 12 Months ]Patients will undergo the clinically indicated procedure for benign esophageal luminal narrowing remediation. Before undergoing clinically indicated esophageal therapy, measurements of the luminal narrowing using EndoFLIP will be obtained to identify potential predictors of response to endoscopic therapy. These measurements will included luminal diameter, length of narrowing and narrowing distensibility and will be obtained before and after delivery of the clinically indicated endoscopic therapy.
- Observation of Post-Endoscopic Therapy EndoFLIP Measurements [ Time Frame: 12 Months ]After undergoing clinically indicated esophageal therapy at clinically-indicated follow-up endoscopies, measurements of the luminal narrowing using EndoFLIP will again be obtained to identify responses to endoscopic therapy.
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): NCT02354716
|Contact: Maureen DeMarshall, BSN, RN||(215) 349 - firstname.lastname@example.org|
|Contact: Carly Price||(215) 349 - email@example.com|
|United States, Pennsylvania|
|University of Pennsylvania||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Maureen Demarshall, BSN, RN, CRC 215-349-8546 firstname.lastname@example.org|
|Contact: Carly Price (215) 349-8556 email@example.com|
|Principal Investigator:||Michael L Kochman, MD||University of Pennsylvania|
|Principal Investigator:||Vinay Chandrasekhara, MD||University of Pennsylvania|
|Principal Investigator:||Gregory G Ginsberg, MD||University of Pennsylvania|