A new method to detect crohns disease in the small intestine

Sonographic diagnostics with oral contrast for Crohns. A novel method for detecting Crohns disease using sonographic intraluminal contrast. - SonoDOCc

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-001710-19-NO

Enrollment

Registered

2022-07-26

Start date

2022-11-01

Completion date

Unknown

Last updated

2026-01-12

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

Conditions

Crohns disease in the terminal ileum

Interventions

Trade Name: Sonazoid Pharmaceutical Form: Powder and solvent for oral solution Trade Name: Laxabon Product Name: Laxabon Pharmaceutical Form: Gastroenteral solution

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with Crohns disease who undergo a full ileocolonoscopy with findings of Crohns disease in the terminal ileum. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 22 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 22

Exclusion criteria

Exclusion criteria: Age 35) Serious heart or lung disease Visible impassable stenosis on endoscopy with normal wall on CEUS

Design outcomes

Primary

Measure	Time frame
Main Objective: Develop a method for investigating the small bowel in Crohn’s disease using transabdominal ultrasound and microbubbles as luminal contrast;Secondary Objective: Investigate feasibility and risk assessment Investigate if inflammation and ulcers are easier to detect using luminal contrast. Investigate if luminal contrast can be used to assess the severity of stenosis. Investigate if motility changes depend on the degree of inflammation defined by ulcer size and intestinal wall thickness. ;Primary end point(s): Successful contrast examination of the terminal ileum in all the study participants;Timepoint(s) of evaluation of this end point: When the 22 patients have been examined, we will verify that all participants have undergone a successful ultrasound contrast examination based on the secondary endpoints	—

Measure

Time frame

Main Objective: Develop a method for investigating the small bowel in Crohn’s disease using transabdominal ultrasound and microbubbles as luminal contrast;Secondary Objective: Investigate feasibility and risk assessment Investigate if inflammation and ulcers are easier to detect using luminal contrast. Investigate if luminal contrast can be used to assess the severity of stenosis. Investigate if motility changes depend on the degree of inflammation defined by ulcer size and intestinal wall thickness. ;Primary end point(s): Successful contrast examination of the terminal ileum in all the study participants;Timepoint(s) of evaluation of this end point: When the 22 patients have been examined, we will verify that all participants have undergone a successful ultrasound contrast examination based on the secondary endpoints

—

Secondary

Measure	Time frame
Secondary end point(s): The contrast reaches the terminal ileum within 2 hours after ingestion. Homogenous contrast filling of the entire lumen of the terminal ileum with a clear separation of the lumen and intestinal wall. ;Timepoint(s) of evaluation of this end point: When the 22 patients have been examined, we will verify that all participants have fulfilled the secondary endpoints	—

Countries

Norway

Contacts

Public ContactNSGU

National Centre for Ultrasound in Gastroenterology (NSGU), Department of Medicine, Haukeland University Hospital

004755973000

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026