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EndoFLIP Use in Upper GI Tract Stenosis

NCT02354716 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 5

Last updated 2019-09-12

No results posted yet for this study

Summary

The purpose of this study is to investigate the use of a functional luminal imaging probe to characterize benign esophageal luminal strictures before and after dilation and identify predictors of response to therapy. Patients will be evaluated during endoscopy using functional luminal imaging (EndoFLIP; Crospon Medical Devices, Galway, Ireland) to characterize the geometry of benign luminal esophageal narrowing before and after dilation.

Conditions

  • Esophageal Stricture
  • Eosinophilic Esophagitis
  • Zenkers Diverticulum
  • Schatzki Ring

Interventions

DEVICE

EndoFLIP

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.

Sponsors & Collaborators

Principal Investigators

  • Michael L Kochman, MD · University of Pennsylvania

  • Vinay Chandrasekhara, MD · University of Pennsylvania

  • Gregory G Ginsberg, MD · University of Pennsylvania

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2019-01-31
Completion
2019-01-31

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT02354716 on ClinicalTrials.gov