NCT03536091

Brief Summary

In this study the investigators aim to evaluate the ability of i-scan OE together with magnification endoscopy to detect and assess microscopic inflammation in patients with inflammator bowel diseases (IBD).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2017

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

Study Start

First participant enrolled

March 1, 2017

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 7, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

May 24, 2018

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

September 26, 2019

Status Verified

September 1, 2019

Enrollment Period

1.3 years

First QC Date

May 7, 2018

Last Update Submit

September 25, 2019

Conditions

Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (2)

  • Assessment of endoscopic Inflammation

    Endoscopic Inflammation will be determined and scored by assessement of the vascular and mucosal pattern under magnification endoscopy.

    12 months

  • Assessment of histopathological Inflammation

    Histopathologic Inflammation will be assessed by grading inflammation of intestinal biopsies routinely obtained during colonoscopy on established pathological scores.

    12 months

Interventions

Magnification endoscopyDIAGNOSTIC_TEST

All IBD patients will undergo magnification endoscopy with 136-fold optical magnification in conjunction with optical chromoendoscopy

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

IBD patients treated in the outpatient department of the University Hospital Erlangen

You may qualify if:

  • Patients with established diagnosis of Inflammatory Bowel Diseases
  • Ability to provide written informed consent
  • Age 18 years and older

You may not qualify if:

  • poor bowel preparation
  • inability to provide written informed consent
  • minors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Erlangen

Erlangen, 91054, Germany

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Endoscopy and Molecular Imaging

Study Record Dates

First Submitted

May 7, 2018

First Posted

May 24, 2018

Study Start

March 1, 2017

Primary Completion

June 1, 2018

Study Completion

July 1, 2018

Last Updated

September 26, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)