Esophageal StrictureEndoFLIPNCT02354716
EndoFLIP Use in Upper GI Tract Stenosis
An observational study of Esophageal Stricture and Eosinophilic Esophagitis, run by University of Pennsylvania at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Esophageal Stricture, Eosinophilic Esophagitis, Zenkers Diverticulum
- What is being tested?
- EndoFLIP
- Type of treatment
- Medical device
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with benign refractory esophageal strictures referred for placement of an esophageal stent are eligible for this study.
Who may be able to join
- > 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
Who cannot join
- < 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Expanding the Clinical Applications of Functional Luminal Imaging (EndoFLIP) in Esophageal Stenoses
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.
Read the 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.
- Being tested
- EndoFLIP
- Keywords
- esophagus, upper GI, endoscopy, endoFLIP, functional luminal imaging, esophageal stricture, narrow esophagus, narrow caliber esophagus, esophageal narrowing, eosinophilic esophagitis, Zenkers diverticulum, Schatzki ring
- Medical subject headings
- Esophageal Stenosis, Eosinophilic Esophagitis, Zenker Diverticulum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoFLIPDevice
Also called Endolumenal Functional Lumenal Imaging Probe
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: EndoFLIP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 Months
Secondary outcomes (2)
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.
Measured: 12 Months
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.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2015 (estimated)
- Study startDec 2014
- Primary completionJan 2019
- Study completionJan 2019
Why it stopped: Lack of patient population
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal StrictureStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael L Kochman, MD, Principal investigator, University of PennsylvaniaVinay Chandrasekhara, MD, Principal investigator, University of PennsylvaniaGregory G Ginsberg, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02354716
- Sponsor's protocol ID
- 819014
- Acronym
- EndoFLIP
- Status last verified
- Sep 2019
- First submitted
- 8 Dec 2014
- Last updated
- 12 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanding the Clinical Applications of Functional Luminal Imaging (EndoFLIP) in Esophageal Stenoses
- ClinicalTrials.gov ID
- NCT02354716
- Acronym / sponsor ID
- EndoFLIP / 819014
- Keywords
- esophagus, upper GI, endoscopy, endoFLIP, functional luminal imaging, esophageal stricture, narrow esophagus, narrow caliber esophagus
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of patient population
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Dec 2014 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 3 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EndoFLIP Measurements | – | Device: EndoFLIPTo 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with benign refractory esophageal strictures referred for placement of an esophageal stent are eligible for this study.
Key inclusion criteria (6 listed)
- > 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
Key exclusion criteria (6 listed)
- < 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EndoFLIPAlso: Endolumenal Functional Lumenal Imaging ProbeThe 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. | Device | EndoFLIP Measurements |
Primary outcome
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.
2 secondary outcomes
Observation of Pre-Endoscopic Therapy EndoFLIP Measurements
Time frame: 12 Months
Observation of Post-Endoscopic Therapy EndoFLIP Measurements
Time frame: 12 Months
Results and safety
The study was stopped early (reason given: Lack of patient population). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael L Kochman, MD principal investigator
University of Pennsylvania
Vinay Chandrasekhara, MD principal investigator
University of Pennsylvania
Gregory G Ginsberg, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Stricture and Eosinophilic Esophagitis, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of patient population). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collection of Measurements of the Luminal Narrowing Using EndoFlip (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2019.