Evaluation of Intraoperative Cellvizio with Intravenous Fluorescein Sodium for Determining Ileal Resection Margins in Crohn's Ileal Disease

The primary objective of the study is to evaluate the intraoperative use of **Cellvizio** with an intravenous injection of **fluorescein** to determine the optimal ileal resection margins in **Crohn's ileal disease**. This is clinically relevant as precise identification of resection margins can potentially reduce the risk of residual disease and improve surgical outcomes for patients with Crohn's disease.

Secondary objectives include: - Evaluating the concordance of Cellvizio with anatomopathology for the study of the ileal serosa to detect transmural Crohn's disease. - Assessing whether the resected mesentery is inflammatory. - Determining the additional bowel length required to achieve microscopically healthy margins. - Creating a video collection of various healthy and pathological aspects of the ileum (mucosa, serosa) and the mesentery.

The clinical trial involves participants diagnosed with **Crohn's ileal disease**, specifically those with end-stage ileal Crohn's disease requiring ileocaecal resection. The study population includes adult patients aged 18 years and older, encompassing both male and female subjects. The trial does not involve a vulnerable population. The sponsor has not provided information regarding the total number of participants. Participants were selected based on their medical condition and the necessity for surgical intervention. Lifestyle factors such as diet, physical activity, or habits are not specified in the available data. The trial aims to evaluate the intraoperative use of Cellvizio with an intravenous injection of fluorescein to determine optimal ileal resection margins in Crohn's disease.

The clinical trial is designed to evaluate the intraoperative use of Cellvizio, utilizing the CelioFlex microsonde, in conjunction with an **intravenous injection** of **fluorescein sodium** to determine optimal ileal resection margins in patients with **Crohn's ileal disease**. This study is structured as a randomized, double-blind, controlled trial, ensuring the reliability and validity of the results. The trial is expected to commence on October 31, 2023, and conclude by October 31, 2025, with the total duration of participant involvement being approximately two years.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on criteria such as being an adult patient aged 18 years or older with end-stage ileal Crohn's disease requiring ileocaecal resection. Following successful screening, participants will be randomized and receive the investigational product, **FLUOCYNE 10%**, administered as a solution for injection. Subsequent follow-up visits will be scheduled to monitor the primary endpoint, which is the microscopic characterization of the ileal mucosal section margin, and secondary endpoints, including the concordance between Cellvizio and pathology for inflammation assessment.

The end-of-study visit will mark the completion of the trial for each participant, during which final assessments will be conducted to evaluate the outcomes. Participants may be subject to early termination from the study if they experience adverse reactions, fail to comply with study procedures, or withdraw consent. The trial aims to provide valuable insights into the effectiveness of using Cellvizio with fluorescein sodium in surgical decision-making for Crohn's ileal disease, potentially improving patient outcomes.

The clinical trial involves the administration of **FLUOCYNE 10%**, a solution for injection containing the active substance **fluorescein sodium**. This experimental medication is provided in the form of a **solution injectable I.V.** and is intended for **intravenous use**. The maximum daily dose is set at 5 ml, with the same amount being the maximum total dose allowed during the treatment period. The administration is designed to occur once, as the maximum treatment period is limited to one day. The pharmaceutical product is manufactured by SERB and is not a pediatric formulation. The chemical origin of the active substance ensures its suitability for the intended clinical application.

In this study, no non-experimental treatments such as standard-of-care therapy, placebo, or comparator treatments are specified. The focus remains solely on the evaluation of the experimental medication, **FLUOCYNE 10%**, in determining the best ileal resection margins in patients with Crohn's ileal disease. Participant compliance with the dosing schedule will be monitored to ensure adherence to the protocol and to assess the efficacy of the treatment in achieving the study's main objective.

Efficacy in the clinical trial will be assessed by evaluating the intraoperative use of Cellvizio, utilizing the CelioFlex microsonde, in conjunction with an intravenous injection of **fluorescein** to determine the optimal ileal resection margins in patients with Crohn's disease. The primary endpoint focuses on the microscopic evaluation of the ileal mucosal section margin, determining whether it is healthy or inflammatory, as assessed by both Cellvizio and pathology. Secondary endpoints include assessing the concordance between Cellvizio and pathology regarding inflammation of the serosa, transmural inflammation, and the mesentery. Additionally, the length of the ileum, measured in centimeters, between the surgical margin and the theoretical resection site in a non-inflammatory area, will be evaluated using Cellvizio on both the mucosa and serosa.