EndoFLIP Use in Upper GI Tract Stenosis

Eosinophilic Esophagitis Clinical Trial

— EndoFLIP  

Official title:

Expanding the Clinical Applications of Functional Luminal Imaging (EndoFLIP) in Esophageal Stenoses

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02354716
• Other study ID #: 819014
• Status: Terminated
• Start date: December 2014
• Est. completion date: January 2019

Study information

• Verified date: September 2019
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

To date there is no effective way to objectively characterize and predict response to endoscopic dilation of luminal strictures of the GI tract. Endoscopic dilation allows effective remediation of benign esophageal and upper GI tract strictures. Stricture dilation is performed after the stricture diameter is crudely gauged by the endoscopist. Stricture characteristics are based on the severity of symptoms and appearance. A stricture may be graded as mild, moderate, severe and as to whether or not the endoscope is able to traverse the luminal narrowing. By precisely measuring the diameter and length of a stricture, the endoscopist can know exactly what type of dilation is necessary. Benign esophageal strictures may also be refractory to dilation and thus require multiple sessions, prior to achieving successful remediation. 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. The study will include patients with strictures referred for endoscopic dilation for the following indications: radiation induced strictures, peptic strictures, RFA induced strictures, EMR induced strictures, eosinophilic esophagitis, Zenkers diverticulum, and strictures related to surgical anastomoses. In patients with benign refractory esophageal strictures referred for endoluminal prostheses EndoFLIP will be used to characterize the stricture prior to stent placement.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• > or = to 18 years of age

• Referred for evaluation and treatment of benign esophageal luminal narrowing

• Clinical diagnosis of benign esophageal luminal narrowing with documentation and imaging

• Adult patients with benign refractory esophageal strictures referred for placement of an esophageal stent are eligible for this study

• Willing and able to give informed consent

• No condition or comorbidity which would prevent the patient from undergoing a successful upper endoscopy

Exclusion Criteria:

• < 18 years of age

• Pregnancy

• History of prior endoscopic dilation* (*unless referred for placement of stent)

• Coagulopathy

• Inability to traverse the stricture using standard techniques

• Patients unable to provide consent

Related Conditions & MeSH terms

• Constriction, Pathologic
• Diverticulum
• Eosinophilic Esophagitis
• Esophageal Stenosis
• Esophageal Stricture
• Esophagitis
• Schatzki Ring
• Zenker Diverticulum
• Zenkers Diverticulum

Intervention

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.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Collection of Measurements of the Luminal Narrowing Using EndoFlip	The study is observational and a proof of concept study. Measurements of the luminal narrowing using EndoFLIP will be obtained.	12 Months
Secondary	Observation of Pre-Endoscopic Therapy EndoFLIP Measurements	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.	12 Months
Secondary	Observation of Post-Endoscopic Therapy EndoFLIP Measurements	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.	12 Months