← Back to Search

Endoscopic Imaging Techniques for Ulcerative Colitis

N/A
Waitlist Available
Led By Raf Bisschops, MD PhD
Research Sponsored by Universitaire Ziekenhuizen Leuven
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the endpoint can be assessed immediately after the endoscopy.
Awards & highlights

Study Summary

This trial is testing new endoscopic imaging techniques to see if they're better than the current gold standard (chromo-endoscopy) for detection neoplastic lesions in patients with longstanding ulcerative colitis.

Who is the study for?
This trial is for adults over 18 with long-term ulcerative colitis (at least 8 years since diagnosis or pancolitis, and at least 10 years for left-sided colitis). They must have had a previous endoscopy over a year ago and be able to give informed consent. It's not for those currently with active ulcerative colitis, personal history of colorectal cancer, allergy to methylene blue, or pregnant women.Check my eligibility
What is being tested?
The study compares traditional chromoendoscopy against newer techniques like NBI, FICE, and I-scan in detecting precancerous changes in patients with longstanding ulcerative colitis. The goal is to see if these new methods are as effective but more efficient than the current gold standard.See study design
What are the potential side effects?
Potential side effects may include discomfort from the endoscopic procedure itself such as cramping or bloating. Allergic reactions could occur in those sensitive to dyes used in chromoendoscopy but this would exclude them from participation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the endpoint can be assessed when pathology results are available : 2 weeks after endoscopy
This trial's timeline: 3 weeks for screening, Varies for treatment, and the endpoint can be assessed when pathology results are available : 2 weeks after endoscopy for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The difference in total number of neoplastic lesions detected by chromoendoscopy and virtual chromoendoscopy
Secondary outcome measures
Duration of total endoscopic procedure time and of endoscopic procedure time during retraction for each technique.
The difference in neoplasia detection rate (i.e. the number of patients with at least one neoplastic lesion) between chromoendoscopy and virtual chromoendoscopy.
The difference in the ratio number of neoplastic lesions/ total number of lesions between chromoendoscopy and virtual chromoendoscopy
Other outcome measures
Number of biopsies per colonoscopy taken in the different groups.
The difference in total number of non-neoplastic lesions detected by chromoendoscopy and virtual chromoendoscopy

Trial Design

6Treatment groups
Experimental Treatment
Active Control
Group I: PENTX i-scanExperimental Treatment1 Intervention
Group F: Virtual chromoendoscopy: HD Pentax colonoscopes and I-scan 2 settings
Group II: OLYMPUS NBIExperimental Treatment1 Intervention
Group B: Virtual chromoendoscopy: HDTV Olympus colonoscopes and Narrow band Imaging (NBI)
Group III: FUJINON FICEExperimental Treatment1 Intervention
Group D: Virtual chromoendoscopy: CCD Fujinon colonoscopes and Fujinon Intelligent Color Enhancement n° 4
Group IV: OLYMPUS CHROMOActive Control1 Intervention
Group A: HDTV Olympus colonoscopes and Chromo-endoscopy, methylene blue 0.1%
Group V: FUJINON CHROMOActive Control1 Intervention
Group C: CCD Fujinon colonoscopes and Chromo-endoscopy, methylene blue 0.1%
Group VI: PENTAX CHROMOActive Control1 Intervention
Group E: HD-Pentax colonoscopes and Chromo-endoscopy, methylene blue 0.1%
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Virtual chromoendoscopy
2015
N/A
~2210

Find a Location

Who is running the clinical trial?

Maastricht University Medical CenterOTHER
938 Previous Clinical Trials
3,258,512 Total Patients Enrolled
5 Trials studying Ulcerative Colitis
6,404 Patients Enrolled for Ulcerative Colitis
Copenhagen University Hospital at HerlevOTHER
114 Previous Clinical Trials
106,348 Total Patients Enrolled
2 Trials studying Ulcerative Colitis
65 Patients Enrolled for Ulcerative Colitis
Universitaire Ziekenhuizen LeuvenLead Sponsor
849 Previous Clinical Trials
1,238,968 Total Patients Enrolled
7 Trials studying Ulcerative Colitis
1,119 Patients Enrolled for Ulcerative Colitis

Media Library

Chromoendoscopy Clinical Trial Eligibility Overview. Trial Name: NCT01882205 — N/A
Ulcerative Colitis Research Study Groups: PENTX i-scan, OLYMPUS CHROMO, OLYMPUS NBI, FUJINON CHROMO, FUJINON FICE, PENTAX CHROMO
Ulcerative Colitis Clinical Trial 2023: Chromoendoscopy Highlights & Side Effects. Trial Name: NCT01882205 — N/A
Chromoendoscopy 2023 Treatment Timeline for Medical Study. Trial Name: NCT01882205 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies available for individuals who wish to partake in this study?

"The clinicaltrials.gov data suggests that this trial has concluded its recruitment process, with the last edit being made on July 25th 2017. Despite this, there are still 408 other trials actively searching for volunteers at present."

Answered by AI
~24 spots leftby Apr 2025