Endoscopically Placed Lumen-Apposing Metal Stents for the Treatment of Symptomatic Intestinal Strictures in Individuals With Inflammatory Bowel Disease
Not applicable · Testing Endoscopically placed lumen-apposing metal stents for the treatment of IBD-strictures · Sites not listed yet · Ottawa Hospital Research Institute
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Endoscopically placed lumen-apposing metal stents for the treatment of IBD-strictures (a procedure) as a possible treatment. Condition(s) listed: Inflammatory Bowel Diseases and Stricture; Bowel.
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- ≥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…
Plus 2 more requirement(s). There are also 9 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 20 participants are expected to take part.
- Start date: 2025-01-01 (planned).
- Main results expected around 2026-09-30 (estimate from the record).
- No study sites are listed yet. Check the official record for contact details.
Main thing being measured
- Clinical success (12-months following stent removal)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Inflammatory Bowel Diseases; Stricture; Bowel |
| Lead sponsor | Ottawa Hospital Research Institute |
| Enrollment | 20 (estimated) |
| Start date | 2025-01-01 |
| Primary completion (est.) | 2026-09-30 |
| First posted | 2024-12-10 |
| Last updated | 2024-12-10 |
| Official title | Endoscopically Placed Lumen-Apposing Metal Stents as a Safe Alternative to Surgery for the Treatment of Symptomatic Intestinal Strictures in Individuals With Inflammatory Bowel Disease |
| ClinicalTrials.gov ID | NCT06725563 |
Interventions
- Endoscopically placed lumen-apposing metal stents for the treatment of IBD-strictures (Procedure)
We will apply standard procedures for endoluminal stenting. A therapeutic colonoscope will be advanced through the bowel up until the stricture. A guidewire will be passed through the lumen at the stricture site. LAMS will be used for strictures \<6cm, with stents ranging in size from 10-16mm in diameter and up to 60mm in length. The stent will be deployed across the stricture with the assistan…
Full eligibility criteria (from the record)
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
Locations (0)
No sites listed yet. The official record has contact information.
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.