TerminatedNot Applicable

EndoFLIP Use in Upper GI Tract Stenosis

Stopped: Lack of patient population

United States5 participantsStarted 2014-12

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Collection of Measurements of the Luminal Narrowing Using EndoFlip

Timeframe: 12 Months

Trial details

NCT IDNCT02354716

SponsorUniversity of Pennsylvania

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2019-01

View on ClinicalTrials.gov More Esophageal Stricture trials