Clinical trial • Not applicable • Gastroenterology

Fluorescein sodium for Crohn's disease (ileal)

Not applicable trial of Fluorescein sodium for Crohn's disease (ileal). open-label. 60 participants.

Overview

open-label Not applicable trial across 1 site in France.

Recruits 60 No vulnerable population selected; participants are adults (≥18). No specific consent/assent handling is described in the CTIS record..

Vulnerable Population: No vulnerable population selected; participants are adults (≥18). No specific consent/assent handling is described in the CTIS record.

{"criterion_text":"- Adult patient ≥ 18 years old"}
{"criterion_text":"- Patient with end-stage ileal Crohn's disease (regardless of phenotype) requiring ileocaecal resection"}

{"criterion_text":"- Patients with Crohn's disease operated on urgently for peritonitis"}
{"criterion_text":"- Patient with a contraindication to the injection of fluorescein (allergy to fluorescein, severe allergy to a drug, moderate to severe renal insufficiency, hepatic insufficiency, history of cardiopulmonary disease, diabetes, concomitant treatments (in particular beta-blockers , including beta-blockers in eye drops)"}

{"endpoint_text":"- is the microscopically healthy or inflammatory character of the ileal mucosal section margin for Cellvizio and pathology.","definition_or_measurement_approach":"Assessment of concordance between intraoperative Cellvizio imaging (with fluorescein) and histopathology to determine whether the ileal mucosal resection margin is microscopically healthy or inflammatory."}

{"endpoint_text":"- The concordance between the Cellvizio with an intravenous injection of fluorescein and the pathology for the inflammation of the serosa (transmural inflammation) and of the mesentery and the length of ileum (in cm) between the surgical margin and the theorical resection site to be in a non-inflammatory area at the Cellvizio (on the mucosa and on the serosa)..","definition_or_measurement_approach":"Assessment of concordance between Cellvizio imaging (with intravenous fluorescein) and histopathology for serosal (transmural) inflammation and mesentery inflammation; measurement in cm of the distance between the surgical margin and the theoretical resection site indicated by Cellvizio on mucosa, serosa and mesentery."}

Investigational Product Name: FLUOCYNE 10%, solution injectable I.V.
Active Substance: Fluorescein sodium
Modality: Small molecule
Routes Of Administration: Intravenous injection | Intracavernous use
Route: Intravenous injection | Intracavernous use
Authorisation Status: Authorised (marketing authorisation in France: 369 542-2)
Maximum Dose: 5 ml

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