EndoFLIP Use in Upper GI Tract Stenosis

NCT02354716 | Terminated

• 1 other identifier: 819014
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

esophagus; upper GI; endoscopy; endoFLIP; functional luminal imaging; esophageal stricture; narrow esophagus; narrow caliber esophagus; esophageal narrowing; eosinophilic esophagitis; Zenkers diverticulum; Schatzki ring

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Observation of Pre-Endoscopic Therapy EndoFLIP Measurements

  12 Months

• Observation of Post-Endoscopic Therapy EndoFLIP Measurements

  12 Months

Study Arms (1)

EndoFLIP Measurements

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.

Device: EndoFLIP

Interventions

EndoFLIP DEVICE

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.

Also known as: Endolumenal Functional Lumenal Imaging Probe

EndoFLIP Measurements

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• \> 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

You may not qualify if:

• \< 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

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Esophageal Stenosis; Eosinophilic Esophagitis; Zenker Diverticulum

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Esophagitis; Gastroenteritis; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Diverticulum, Esophageal; Diverticulum; Diverticular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael L Kochman, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Vinay Chandrasekhara, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Gregory G Ginsberg, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2014
• First Posted: February 3, 2015
• Study Start: December 1, 2014
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: September 12, 2019

Record last verified: 2019-09

Locations

US (1)