perflubutane for Crohn's disease

Stratification factors

• Disease activity group (Remission; Stenosis: passable vs impassable; Ulcers: inflammation/small ulcers vs large ulcers; Healthy volunteer)

Inclusion criteria

• {"criterion_text":"-Patients >18 years old with Crohn’s disease in the terminal ileum who undergo ileocolonoscopy"}
• {"criterion_text":"-Healthy volunteers > 18 years without known gastrointestinal illnesses"}
• {"criterion_text":"-Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol"}

Exclusion criteria

• {"criterion_text":"-Age<18 years"}
• {"criterion_text":"-Known egg allergy"}
• {"criterion_text":"-Pregnancy"}
• {"criterion_text":"-Breastfeeding"}
• {"criterion_text":"-Severe obesity (BMI >35)"}
• {"criterion_text":"-Serious heart or lung disease"}
• {"criterion_text":"-Change in treatment for Crohn’s disease between endoscopy/ultrasound and contrast ultrasound examination"}

Primary endpoints

• {"endpoint_text":"-Number of patients with homogenous contrast filling of the entire lumen of the terminal ileum within 1 hours of ingestion, with a clear separation between the lumen and intestinal wall as visually assessed by the examiner.","definition_or_measurement_approach":"Visual assessment by the examiner within 1 hour of ingestion; endpoint is count of patients with homogenous contrast filling and clear separation between lumen and intestinal wall."}

Secondary endpoints

• {"endpoint_text":"-Number of patients who develop adverse events and severe adverse events","definition_or_measurement_approach":"Recording and counting adverse events and severe adverse events as reported during/after the procedure."}
• {"endpoint_text":"-Number of patients who are willing to undergo the procedure again","definition_or_measurement_approach":"Patient-reported willingness to repeat the procedure."}
• {"endpoint_text":"-Number of patients with detected stenosis in the terminal ileum with and without contrast, as visually assessed by the examiner and confirmed on endoscopy.","definition_or_measurement_approach":"Visual assessment by examiner with comparison of findings with and without contrast; confirmation by endoscopy."}
• {"endpoint_text":"-Number of patients with detected ulcers >0,5cm in the terminal ileum with and without contrast, as visually assessed by the examiner and confirmed on endoscopy","definition_or_measurement_approach":"Visual assessment by examiner with and without contrast for ulcers >0.5 cm; confirmation on endoscopy."}
• {"endpoint_text":"-Number of patients with large (0,5cm-2cm) and very large (>2cm) ulcers in the terminal ileum with and without contrast, as visually assessed by the examiner and confirmed on endoscopy.","definition_or_measurement_approach":"Visual size-based classification of ulcers with and without contrast; confirmation by endoscopy."}
• {"endpoint_text":"-Interobserver variability for wall thickness in the terminal ileum with and without contrast as visually assessed by the examiner.","definition_or_measurement_approach":"Assessment of interobserver variability (comparison between examiners) of wall thickness measurements with and without contrast."}
• {"endpoint_text":"-Number of patients with visible intestinal contractions with and without contrast","definition_or_measurement_approach":"Visual assessment counting patients with observable intestinal contractions during ultrasound with and without contrast."}
• {"endpoint_text":"-Number of patients with ulcers and visible intestinal contractions in the terminal ileum","definition_or_measurement_approach":"Combined assessment: presence of ulcers and observable contractions as visually assessed."}
• {"endpoint_text":"-Number of patients with stenosis and visible intestinal contractions in the terminal ileum","definition_or_measurement_approach":"Combined assessment: presence of stenosis and observable contractions as visually assessed."}
• {"endpoint_text":"-The correlation between ulcer size, bowel wall thickness and frequency of contractions in the terminal ileum.","definition_or_measurement_approach":"Statistical correlation analysis between measured ulcer size, bowel wall thickness and contraction frequency."}
• {"endpoint_text":"-The correlation of motility findings in Crohn’s patients and healthy volunteers","definition_or_measurement_approach":"Comparative analysis/correlation of motility measurements between patients and healthy volunteers."}
• {"endpoint_text":"-The number of patients with detected disease activity in the neoterminal ileum with and without contrast.","definition_or_measurement_approach":"Visual assessment of disease activity in neoterminal ileum with and without contrast; count of patients detected."}

Norway

Earliest CTIS Part Ii Submission Date

31-03-2025

Latest Decision Or Authorization Date

11-04-2025

Processing Time Days

11

Number Of Sites

1

Number Of Participants

104

Primary sponsor

Full Name

Helse Bergen HF

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Norway