Endoscopically Placed Lumen-Apposing Metal Stents for the Treatment of Symptomatic Intestinal Str… (NCT06725563) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Endoscopically Placed Lumen-Apposing Metal Stents for the Treatment of Symptomatic Intestinal Strictures in Individuals With Inflammatory Bowel Disease
20 participantsStarted 2025-01-01
Plain-language summary
This is a single-center prospective pilot study in patients with symptomatic partially obstructing intestinal strictures without severe active inflammation or penetrating complications, evaluating the use of LAMS with respect to symptom and quality of life improvement and the development of stent-related complications.
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:
* ≥18 years of age
* Established Diagnosis of inflammatory bowel disease
* Symptomatic, single, fibrostenotic or anastomotic stricture \<6 cm in length without severe active inflammation, pre-stenotic intestinal fistula or penetrating complication, and within reach of the adult colonoscope (colon or terminal ileum)
* Ability to accurately gauge stricture length with imaging and safely deploy the stent using conventional fluoroscopic techniques
* Able to provide informed consent
Exclusion Criteria:
* More than one intestinal stricture
* Stricture out of reach of standard adult colonoscope
* High-grade stricture (complete or near complete bowel obstruction
* Severe active inflammation in the stricture or associated penetrating complication, including fistula, inflammatory phlegmon or abscess
* Contraindications for endoscopic therapy, including:
* Complete Bowel obstruction
* Severe cardiorespiratory comorbidity
* Unable to tolerate sedation or anesthesia
* Non-reversible coagulopathy
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.