Endoscopically Placed Lumen-Apposing Metal Stents for the Treatment of Symptomatic Intestinal Strictures in Individuals With Inflammatory Bowel Disease

Sponsor
Ottawa Hospital Research Institute
Study ID
NCT06725563
Status
Not Yet Recruiting

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Conditions

  • Inflammatory Bowel Diseases
  • Stricture; Bowel

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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 assistance of endoscopic and fluoroscopic imaging. Individuals will undergo a repeat colonoscopy in 1-3 months to remove the stent.

Study Details

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.

Key Dates

First listed
Dec 10, 2024
Start date
Jan 1, 2025
Status verified
Dec 2024
Primary completion
Sep 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Endoscopically placed lumen-apposing metal stents for the treatment of IBD-strictures
    Individuals will receive endoscopic lumen-apposing metal stents. The specific size of the stent used will depend on the length of the stricture. All LAMS placements are part of one arm.

Primary Outcome Measure

Clinical success [ Time Frame: 12-months following stent removal ]

Central Contacts

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