Overview
Sponsor-declared trial summary
Crohn's ileal disease
to evaluate the intraoperative use of Cellvizio (using the CelioFlex microsonde) with an intravenous injection of fluorescein to determine the best ileal resection margins in Crohn disease.
Key facts
- Sponsor
- Centre Hospitalier Universitaire Amiens Picardie
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Phenomena and Processes [G] - Digestive System and Oral Physiological Phenomena [G10]
- Trial duration
- 31 Oct 2023 → ongoing
- Decision date (initial)
- 2024-08-22
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-517220-19-00
- EudraCT number
- 2022-003499-18
- ClinicalTrials.gov
- NCT05805020
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Diagnosis
to evaluate the intraoperative use of Cellvizio (using the CelioFlex microsonde) with an intravenous injection of fluorescein to determine the best ileal resection margins in Crohn disease.
Secondary objectives 1
- Evaluate the interest of Cellvizio with the intravenous injection of fluorescein intraoperatively (concordance with the anatomopathology): - for the study of the ileal serosa for (search for transmural Crohn's disease) - to assess whether or not the resected mesentery is inflammatory Assess the additional bowel length that would need to be resected to be microscopically healthy at the margin. To constitute a video collection of the different healthy and pathological aspects of the hail (mucosa, serosa) but also of the mesentery
Conditions and MedDRA coding
Crohn's ileal disease
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Adult patient ≥ 18 years old
- Patient with end-stage ileal Crohn's disease (regardless of phenotype) requiring ileocaecal resection
Exclusion criteria 2
- - Patients with Crohn's disease operated on urgently for peritonitis
- 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)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- is the microscopically healthy or inflammatory character of the ileal mucosal section margin for Cellvizio and pathology.
Secondary endpoints 1
- 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)..
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
FLUOCYNE 10%, solution injectable I.V.
PRD345647 · Product
- Active substance
- Fluorescein Sodium
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRACAVERNOUS USE
- Max daily dose
- 5 ml millilitre(s)
- Max total dose
- 5 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- S01JA01 — FLUORESCEIN
- Marketing authorisation
- 369 542-2
- MA holder
- SERB
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Universitaire Amiens Picardie
- Sponsor organisation
- Centre Hospitalier Universitaire Amiens Picardie
- Address
- 1 Rond Point Du Pr Christian Cabrol
- City
- Amiens Cedex 1
- Postcode
- 80054
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire Amiens Picardie
- Contact name
- Charles SABBAGH
Public contact point
- Organisation
- Centre Hospitalier Universitaire Amiens Picardie
- Contact name
- Charles SABBAGH
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 60 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2023-10-31 | 2023-10-31 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 9 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_CELLVICROHN_2024-517220-19-00 _Clean | 3.1 |
| Protocol (for publication) | D1_Protocol_CELLVICROHN_2024-517220-19-00 _TC | 3.1 |
| Protocol (for publication) | D1_PROTOCOLE_2024-517220-19-00 | 3 |
| Recruitment arrangements (for publication) | NON APPLICABLE | 1 |
| Subject information and informed consent form (for publication) | L1_SIS_and_ICF_ Patients | 2.2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_fluoresceine | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_CELLVICROHN_2024-517220-19-00 _Clean | 3.1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_CELLVICROHN_2024-517220-19-00 _TC | 3.1 |
| Synopsis of the protocol (for publication) | D1_PROTOCOL_SYNOPSIS_Fr_2024-517220-19-00 | 3 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-13 | France | Acceptable 2024-08-21
|
2024-08-22 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-11-17 | France | Acceptable 2026-01-14
|
2026-01-14 |