NCT06223347

Brief Summary

Comparing chromoendoscopy to a digital staining technique and White light in patients with IBD attending scheduled surveillance colonoscopy

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
106

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2024

Typical duration for all trials

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 1, 2024

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 25, 2024

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

January 25, 2024

Status Verified

January 1, 2024

Enrollment Period

2.2 years

First QC Date

January 16, 2024

Last Update Submit

January 16, 2024

Conditions

ColitisColonic DysplasiaInflammatory Bowel DiseasesColonoscopySurveillance

Outcome Measures

Primary Outcomes (1)

  • Dysplasia detection rate

    Dysplasia detection rate for each staining technique

    90 minutes

Secondary Outcomes (4)

  • Hyperplasia detection rate

    90 minutes

  • Adenoma detection rate, ADR

    90 minutes

  • Bowel cleansing quality according to Bowel Boston Preparation Scale

    90 minutes

  • Serious adverse events (significant bleedings and perforations)

    90 minutes

Interventions

ChromoendoscopyDIAGNOSTIC_TEST

Chromoendoscopy: is a dye based staining of colonic mucosa. NBI: is an optical image enhancing technology that allows a detailed inspection of vascular and mucosal patterns, providing the ability to predict histology during real-time endoscopy. TXI: is a digital technique that enhance texture and color of the tissues to be more visible.

Also known as: NBI(Narrow Band Imaging), WLI(White light), TXI( Texture and Colour Enhancement Imaging)

Eligibility Criteria

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

Our study is directed to the IBD patients who have to undergo a surveillance colonscopy to early detection of dysplasia.

You may qualify if:

  • \- Person schedules to IBD- surveillance colonoscopy.

You may not qualify if:

  • Total Colectomy.
  • Not well prepared Bowel. BBPS under 2 at any segement.
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, Molndal, 43180, Sweden

RECRUITING

MeSH Terms

Conditions

ColitisInflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesColonic DiseasesIntestinal Diseases

Central Study Contacts

Naz Mohammed Salih, Dr.

CONTACT

+46720267227naz.mohammed.salih@vgregion.se

Study Design

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

Study Record Dates

First Submitted

January 16, 2024

First Posted

January 25, 2024

Study Start

January 1, 2024

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

January 25, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)