SonoDOCc 2

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Helse Bergen HF

Participant type

Patients, Healthy volunteers

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Trial duration

12 Sep 2025 → ongoing

Decision date (initial)

2025-04-11

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Karla og Arne Oddmars Medisinske fond · Norsk Forening for ultralyd diagnostikk · Helse Vest

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Diagnosis, Efficacy

Develop a method for investigating the small bowel in Crohn’s disease using transabdominal ultrasound and microbubbles as luminal contrast.

Secondary objectives 12

1. Investigate adverse events and severe adverse events
2. Investigate tolerability of the procedure
3. Investigate if luminal contrast can be used to detect stenosis in the terminal ileum
4. Investigate if luminal contrast can be used to detect ulcers >0,5cm in the terminal ileum
5. Investigate if luminal contrast can be used to separate large ulcers (0.5-2 cm) and very large ulcers (>2 cm) in the terminal ileum
6. Investigate if luminal contrast affects the measurement of wall thickness in the terminal ileum
7. Investigate if luminal contrast can be used to detect motility in the small intestine
8. Investigate intestinal motility in patients with ulcers in the terminal ileum.
9. Investigate intestinal motility in patients with stenosis in the terminal ileum.
10. Investigate if intestinal motility is affected by the degree of inflammation defined by ulcer size and intestinal wall thickness.
11. Investigate if there are differences in motility findings between patients with Crohn’s disease and healthy volunteers.
12. Investigate if luminal contrast can be used to detect postsurgical relapse in the neoterminal ileum.

Conditions and MedDRA coding

Crohn's disease

Study design 1 period

Regulatory references

Plan to share IPD

No

IPD plan description

Participant data will only be available for principal investigator and appointed co-investigators/researchers in this study. There will be no sharing of data with other hospitals or other organisations outside of our research group.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Patients >18 years old with Crohn’s disease in the terminal ileum who undergo ileocolonoscopy
2. Healthy volunteers > 18 years without known gastrointestinal illnesses
3. 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 7

1. Age<18 years
2. Known egg allergy
3. Pregnancy
4. Breastfeeding
5. Severe obesity (BMI >35)
6. Serious heart or lung disease
7. Change in treatment for Crohn’s disease between endoscopy/ultrasound and contrast ultrasound examination

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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 endpoints 12

1. Number of patients who develop adverse events and severe adverse events
2. Number of patients who are willing to undergo the procedure again
3. Number of patients with detected stenosis in the terminal ileum with and without contrast, as visually assessed by the examiner and confirmed on endoscopy.
4. 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
5. 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.
6. Interobserver variability for wall thickness in the terminal ileum with and without contrast as visually assessed by the examiner.
7. Number of patients with visible intestinal contractions with and without contrast
8. Number of patients with ulcers and visible intestinal contractions in the terminal ileum
9. Number of patients with stenosis and visible intestinal contractions in the terminal ileum
10. The correlation between ulcer size, bowel wall thickness and frequency of contractions in the terminal ileum.
11. The correlation of motility findings in Crohn’s patients and healthy volunteers
12. The number of patients with detected disease activity in the neoterminal ileum with and without contrast.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Helse Bergen HF

Sponsor organisation

Helse Bergen HF

Address

Haukelandsveien 22

City

Bergen

Postcode

5021

Country

Norway

Scientific contact point

Organisation

Helse Bergen HF

Contact name

Kim Nylund

Public contact point

Organisation

Helse Bergen HF

Contact name

Kahtan Al-Azawy

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 8 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications