NCT03439826

Brief Summary

Observational study

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

February 13, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

February 13, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 20, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

June 19, 2019

Status Verified

June 1, 2019

Enrollment Period

1.1 years

First QC Date

February 13, 2018

Last Update Submit

June 18, 2019

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (1)

  • Inter-observer reproducibility (junior / senior) of an ultrasound score of Crohn's disease activity

    These criteria are to be found on each segment: terminal ileum, right colon, transverse colon, left colon and sigmoid. * Normal appearance: yes / no * Maximum parietal wall thickness (mm) * parietal differentiation: yes / no * Ulceration: yes / no * Fistula: yes / no * Infiltration of peripheral fat: yes / no * Sclerolipomatosis: yes / no * Stenosis: yes / no Criterion for the entire abdominal cavity : * Mesangular ganglion\> 5mm: yes / no * Intraperitoneal fluid effusion: yes / no Abdominal abscess: yes / no * dilated handles: yes / no * Total length of reach (in mm) * Distance to the valve

    Baseline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients followed for Crohn's disease

You may qualify if:

  • Patients followed for Crohn's disease;
  • Crohn's disease diagnosed in accordance with the criteria of the European Crohn's and Colitis Organization (ECCO);
  • Benefiting from an abdominal ultrasound as part of their usual follow-up;
  • Not having expressed his opposition to participate in the study.

You may not qualify if:

  • Persons of legal age subject to legal protection (protection of justice, guardianship, tutorship), persons deprived of their liberty.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rennes University Hospital

Rennes, 35033, France

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Guillaume Bouguen

    Rennes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2018

First Posted

February 20, 2018

Study Start

February 13, 2018

Primary Completion

April 1, 2019

Study Completion

April 1, 2019

Last Updated

June 19, 2019

Record last verified: 2019-06

Locations

FR(1)