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EndoFLIP Use in Upper GI Tract Stenosis (EndoFLIP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2017 by University of Pennsylvania
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT02354716
First received: December 8, 2014
Last updated: January 25, 2017
Last verified: January 2017
  Purpose
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.

Condition Intervention
Esophageal Stricture
Eosinophilic Esophagitis
Zenkers Diverticulum
Schatzki Ring
Device: EndoFLIP

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Expanding the Clinical Applications of Functional Luminal Imaging (EndoFLIP) in Esophageal Stenoses

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 100
Study Start Date: December 2014
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
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

Detailed 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.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02354716

Contacts
Contact: Maureen DeMarshall, BSN, RN (215) 349 - 8546 demarshm@mail.med.upenn.edu
Contact: Carly Price (215) 349 - 8556 carly.price@uphs.upenn.edu

Locations
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Maureen Demarshall, BSN, RN, CRC    215-349-8546    demarshm@mail.med.upenn.edu   
Contact: Carly Price    (215) 349-8556    carly.price@uphs.upenn.edu   
Sponsors and Collaborators
University of Pennsylvania
Investigators
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
  More Information

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02354716     History of Changes
Other Study ID Numbers: 819014
Study First Received: December 8, 2014
Last Updated: January 25, 2017

Keywords provided by University of Pennsylvania:
esophagus
upper GI
endoscopy
endoFLIP
functional luminal imaging
esophageal stricture
narrow esophagus
narrow caliber esophagus
esophageal narrowing
eosinophilic esophagitis
Zenkers diverticulum
Schatzki ring

Additional relevant MeSH terms:
Esophagitis
Constriction, Pathologic
Eosinophilic Esophagitis
Diverticulum
Esophageal Stenosis
Zenker Diverticulum
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Pathological Conditions, Anatomical
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Diverticulum, Esophageal
Phenobarbital
Anticonvulsants
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
GABA Modulators
GABA Agents
Cytochrome P-450 CYP2B6 Inducers

ClinicalTrials.gov processed this record on March 27, 2017