Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

EndoFLIP Use in Upper GI Tract Stenosis (EndoFLIP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02354716
Recruitment Status : Terminated (Lack of patient population)
First Posted : February 3, 2015
Last Update Posted : September 12, 2019
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Tracking Information
First Submitted Date December 8, 2014
First Posted Date February 3, 2015
Last Update Posted Date September 12, 2019
Actual Study Start Date December 2014
Actual Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 29, 2015)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 29, 2015)
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title EndoFLIP Use in Upper GI Tract Stenosis
Official Title Expanding the Clinical Applications of Functional Luminal Imaging (EndoFLIP) in Esophageal Stenoses
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.
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.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Esophageal Stricture
  • Eosinophilic Esophagitis
  • Zenkers Diverticulum
  • Schatzki Ring
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.
Other Name: Endolumenal Functional Lumenal Imaging Probe
Study Groups/Cohorts 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.
Intervention: Device: EndoFLIP
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: September 10, 2019)
5
Original Estimated Enrollment
 (submitted: January 29, 2015)
100
Actual Study Completion Date January 2019
Actual Primary Completion Date January 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02354716
Other Study ID Numbers 819014
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Pennsylvania
Study Sponsor University of Pennsylvania
Collaborators Not Provided
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
PRS Account University of Pennsylvania
Verification Date September 2019