Crohn'sRecruiting
Pre-stenotic Inflammation Following Endoscopic Balloon Dilatation in Crohn's Disease: A Prospective Study
Observational · No treatment assigned · 1 site · Shaare Zedek Medical Center
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Crohn Disease. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Age range not stated in the record
- Any sex
Some of the main requirements, copied from the record:
- Patients diagnosed with CD as per most recent international guidelines.
- Presence of strictured bowel (jejunal, ileal, colonic or ileocecal valve), either primary or anastomotic in nature, with prestenotic dilatation >2.5cm loop diameter as demonstrated on cross-sectional imaging (Magentic Resonance…
- Evidence of pre-stenotic inflammation defined as wall thickness ≥5mm on cross-sectional imaging, or pre-stenotic SES-CD ≥3.
Plus 3 more requirement(s). There are also 2 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 24 participants are expected to take part.
- Start date: 2020-11-01.
- Main results expected around 2028-10 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Israel.
Main thing being measured
- Endoscopic response (12 weeks compared to week 0)
In the researchers’ words
As a consequence of chronic relapsing inflammation in Crohn's disease (CD), progressive bowel damage and scarring occurs in affected regions of intestine. This damage often leads to narrowing, or stricturing of the bowel lumen, and even complete bowel obstruction.
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 | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Crohn Disease |
| Lead sponsor | Shaare Zedek Medical Center |
| Collaborators | Sheffield Children's NHS Foundation Trust; Bambino Gesù Hospital; University of Roma La Sapienza; Hopital Universitaire Robert-Debre |
| Enrollment | 24 (estimated) |
| Start date | 2020-11-01 |
| Primary completion (est.) | 2028-10 |
| First posted | 2021-03-18 |
| Last updated | 2025-05-22 |
| Official title | Pre-stenotic Inflammation Following Endoscopic Balloon Dilatation in Crohn's Disease: A Prospective Study |
| ClinicalTrials.gov ID | NCT04803916 |
Interventions
- None listed
Full eligibility criteria (from the record)
Inclusion criteria: * Patients diagnosed with CD as per most recent international guidelines. * Presence of strictured bowel (jejunal, ileal, colonic or ileocecal valve), either primary or anastomotic in nature, with prestenotic dilatation >2.5cm loop diameter as demonstrated on cross-sectional imaging (Magentic Resonance Enteroclysis (MRE), Computerized Tomography Enteroclysis (CTE) or ultrasound (US)) * Evidence of pre-stenotic inflammation defined as wall thickness ≥5mm on cross-sectional imaging, or pre-stenotic SES-CD ≥3. * Planned EBD as per clinical management. * Unchanged CD medications - 3 months no change in therapy including immunomodulators (thiopurines or methotrexate), biological therapies, corticosteroid therapy, or nutritional therapy with exclusive enteral nutrition (EEN) or partial enteral nutrition (PEN). * No planned treatment changes or additions over the 3 months following recruitment. The treating physician can change treatment at any time should the clinical need arise however the patient will be excluded from primary analysis Exclusion criteria: * Any patient deemed not appropriate for EBD by treating physician due to stricture- specific, or patient-specific reasons will not be included * Change in therapy (dose or type) in the 3 months prior to planned EBD
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Shaare Zedek | Jerusalem | Israel | Recruiting |
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.