NCT06833450

Brief Summary

Transabdominal intestinal ultrasound (IUS) is gaining acceptance as a point-of-care test to objectively assess disease activity in Crohn's disease (CD). In order to incorporate individual parameters in a future definition of transmural healing, and for the consistent application of IUS as a modality to assess treatment outcomes and establish therapeutic targets to ensure comparability between future studies, the inter-observer agreement should be determined for all relevant parameters.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 19, 2022

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

February 13, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 18, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

February 18, 2025

Status Verified

February 1, 2025

Enrollment Period

4 years

First QC Date

February 13, 2025

Last Update Submit

February 13, 2025

Conditions

Crohn Disease (CD)

Keywords

Crohn's diseaseintestinal ultrasoundbowel wall thickness

Outcome Measures

Primary Outcomes (1)

  • Number of different IUS parameters between two operators

    To assess in patients with CD the variability of IUS parameters between two operators

    1 year

Interventions

Transabdominal intestinal ultrasoundOTHER

Transabdominal intestinal ultrasound

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Crohn's disease evolving for at least 1 months
  • Patient older than 18 years
  • Patient covered by French national health insurance
  • Written informed consent

You may not qualify if:

  • Pregnant women or breastfeeding
  • Minor
  • Patient deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU d'Amiens

Amiens, 80054, France

RECRUITING

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Central Study Contacts

Mathurin Fumery, Pr

CONTACT

33+3 22 08 88 40Fumery.mathurin@chu-amiens.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2025

First Posted

February 18, 2025

Study Start

January 19, 2022

Primary Completion

February 1, 2026

Study Completion

February 1, 2026

Last Updated

February 18, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)