CompletedNot Applicable

UAS-RBS: a Safety Study

Belgium11 participantsStarted 2018-03-27

Plain-language summary

A novel stent, called Universal Partially Covered Removable Self-expanding Stent and Anchoring System for the Treatment of Refractory Benign Esophageal Strictures (UAS-RBS) was designed to improve the treatment of benign esophageal refractory strictures with a novel stent. This study aims at evaluating the safety of this new device.

Who can participate

Age range

18 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: * Benign Esophageal Refractory Stricture no more than 40 mm in length. * More than two dilations to at least 16 mm in diameter with symptoms relapse within 6 months. * Last dilation to 16 mm no more than 6 months before study procedure. * Dysphagia score of 2 (ability to swallow semi-solid foods), 3 (ability to swallow liquids only) or 4 (unable to swallow liquids) at the time of measurement. * Willing and able to comply with the study procedures and provide written informed consent to participate in the study. Exclusion Criteria: * Stricture within 2 cm of the upper esophageal sphincter. * Dysphagia related to motility disorder. * Planned adjuvant radiation therapy post esophagectomy. * Esophageal stent in place. * Active erosive esophagitis. * Sensitivity to any components of the stent or delivery system. * Concurrent medical condition that would affect the investigator's ability to evaluate the patient's condition or could compromise patient safety. * Currently enrolled in another clinical trial.

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

Incidence of all Adverse Device Effects

Timeframe: 6 months

Technical stent placement success

Timeframe: Day 0

Full deployment of stent

Timeframe: Day 0

Technical stent removal success

Timeframe: up to 6 months

Trial details

NCT IDNCT03652285

SponsorErasme University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-03-31

View on ClinicalTrials.gov More Refractory Benign Strictures trials