Last reviewed · How we verify

NCT03481751

Validation and Interobserver Reliability of a Simple Ultrasound Score for Crohn's Disease

Status unknown Last updated 4 October 2022
What this trial tests

trial testing Diagnostic test: Ultrasound in Crohn Disease in 124 participants. Status unknown.

Timeline
8 January 2018
Primary endpoint
20 December 2020
20 December 2022

Quick facts

Lead sponsorHaukeland University Hospital
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment124
Start date8 January 2018
Primary completion20 December 2020
Estimated completion20 December 2022
Sites3 locations across Norway

Drugs / interventions tested

Conditions studied

Sponsor

Haukeland University Hospital

Who can join

Adults 18 to 75, any sex, with Crohn Disease or Ultrasound. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Crohn's disease (CD) is a chronic inflammatory disease in the gastrointestinal (GI) tract. It is characterized by an alternating course between remission and relapse, which necessitates subsequent adjustments in medical therapy. Thus, it is important to have suitable tools to assess disease activity, and currently the reference standard is using ileocolonoscopy. However, ileocolonoscopy causes major patient discomfort and due to logistic reasons, it cannot be performed on a regular basis. High frequency ultrasound (US) is a potentially useful tool to evaluate changes in disease activity in affected bowel segments. Although there are some studies using US in CD patients to construct ultrasonographic scoring systems, there are no validated scores in daily clinical practice. In a recent study by Nylund et al, we used multiple linear regression to select which simple conventional ultrasound parameters that should be included in an ultrasound scoring system (Simple Ultrasound Score of Crohn's Disease (SUS-CD)) using endoscopy as a reference (unpublished data). In this study, we aim to validate this scoring system using an endoscopic score (Simple endoscopic activity score for Crohn's disease (SES-CD)) as reference standard and to assess interobserver variability. The scoring system might be a useful supplement to endoscopy to follow up CD patients.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Development and Validation of a Simple Ultrasound Activity Score for Crohn's Disease.
    Sævik F, Eriksen R, Eide GE, Gilja OH, et al · · 2021 · cited 86× · PMID 32504533 · DOI 10.1093/ecco-jcc/jjaa112
  2. Integrating Intestinal Ultrasound to Clinical Trials in Patients With Crohn's Disease: Opportunities and Challenges.
    Jairath V, Adsul S, Allocca M, Danese S, et al · · 2025 · cited 2× · PMID 40971817 · DOI 10.1093/ibd/izaf196

Verify or expand the search:

Other recruiting trials for Crohn Disease

Currently open trials in the same condition.

Other Haukeland University Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03481751.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing