Cellvizio to Evaluate Margins in Crohn's Ileal Disease
Not applicable · Testing cellvizio · 1 site · Centre Hospitalier Universitaire, Amiens
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing cellvizio (a procedure) as a way to diagnose or measure disease. Condition(s) listed: Crohn Disease, Resection Margins and Recurrence.
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:
- Patients who need a ileocaecal resection for a Crohn disease whatever is the phenotype of the Crohn's disease
There are also 5 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 41 participants are expected to take part.
- Start date: 2022-03-03.
- Main results expected around 2026-03 (estimate from the record).
- 1 study site listed (1 marked recruiting) in France.
Main thing being measured
- concordance between the Cellvizio pictures and the pathology incidence (2 years)
In the researchers’ words
Crohn disease is an inflammatory bowel disease. A surgical procedure is required in about 80% of cases.
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 | Not applicable |
| Study type | Interventional |
| Conditions | Crohn Disease; Resection Margins; Recurrence |
| Lead sponsor | Centre Hospitalier Universitaire, Amiens |
| Enrollment | 41 (estimated) |
| Start date | 2022-03-03 |
| Primary completion (est.) | 2026-03 |
| First posted | 2023-04-07 |
| Last updated | 2025-05-28 |
| Official title | Is There a Concordance Between the Cellvizio With an Intravenous Injection of Fluorescein and the Pathology to Determine the Microscopic Inflammation at the Ileal Resection Margins in Crohn's Ileal Disease |
| ClinicalTrials.gov ID | NCT05805020 |
Interventions
- cellvizio (Procedure)
During surgery an intravenous injection of fluorescein will be performed. The surgeon will, then, evaluate the ileal section margins on the mucosa, the serosa and the mesentery to evaluate if the section margin in microscopically inflammatory or not. She/he will then evaluate (in cm) the length between this section margin and the theorical section margin to be on a non-inflammatory tissue on the m…
Full eligibility criteria (from the record)
Inclusion Criteria: * Patients who need a ileocaecal resection for a Crohn disease whatever is the phenotype of the Crohn's disease Exclusion Criteria: * Patients<18 years old, * pregnancy or breastfeeding, * patients who have an ileocolic resection for a surgical recurrence of the Crohn's disease. * Patients operated in emergency for a peritonitis, * patients who have a contra-indication for fluorescein injection or severe allergia to any drug
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Amiens Picardie | Amiens | France | 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.