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Sonographic Diagnostics with Oral Contrast for Crohn’s disease 2. A novel method for detecting Crohns disease using sonographic intraluminal contrast

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-508500-38-00
Acronym
Luminal Sonazoid 002
Enrollment
104
Registered
2025-04-11
Start date
2025-09-12
Completion date
Unknown
Last updated
2025-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's disease

Brief summary

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.

Detailed description

Number of patients who develop adverse events and severe adverse events, Number of patients who are willing to undergo the procedure again, Number of patients with detected stenosis in the terminal ileum with and without contrast, as visually assessed by the examiner and confirmed on endoscopy., 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, 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., Interobserver variability for wall thickness in the terminal ileum with and without contrast as visually assessed by the examiner., Number of patients with visible intestinal contractions with and without contrast, Number of patients with ulcers and visible intestinal contractions in the terminal ileum, Number of patients with stenosis and visible intestinal contractions in the terminal ileum, The correlation between ulcer size, bowel wall thickness and frequency of contractions in the terminal ileum., The correlation of motility findings in Crohn’s patients and healthy volunteers, The number of patients with detected disease activity in the neoterminal ileum with and without contrast.

Interventions

DRUGLaxabon pulver til mikstur
DRUGoppløsning i doseposer a 68
DRUG5 g.

Sponsors

Helse Bergen HF
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
Number of patients who develop adverse events and severe adverse events, Number of patients who are willing to undergo the procedure again, Number of patients with detected stenosis in the terminal ileum with and without contrast, as visually assessed by the examiner and confirmed on endoscopy., 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, 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., Interobserver variability for wall thickness in the terminal ileum with and without contrast as visually assessed by the examiner., Number of patients with visible intestinal contractions with and without contrast, Number of patients with ulcers and visible intestinal contractions in the terminal ileum, Number of patients with stenosis and visible intest

Countries

Norway

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026