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Status unknownNCT02049775Updated Feb 19, 2016

Utilization of NBi in Assessing Luminal INflammaion in IBD (UNBLIND)

An interventional study of NBI in Ulcerative Colitis (UC), sponsored by The Leeds Teaching Hospitals NHS Trust. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2016-02-19.

Sponsored by The Leeds Teaching Hospitals NHS Trust · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Feb 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Allocation
Not applicable
Ages
18 Years to 85 Years
Sex
All
01

Study summary

Ulcerative colitis (UC) is a chronic inflammatory condition of unknown aetiology, characterized by a diffuse confluent mucosal inflammation of the colon starting from the rectum with a relapsing and remitting course. Conventional endoscopy was thought to be a reliable parameter of disease activity, but microscopic inflammation can persist despite normal mucosal findings. Histologically detectable inflammation is associated with a greater risk of subsequent relapse. A flare in UC activity is difficult to predict, but a simple, easily measured biological marker of relapse would be important in guiding the most appropriate therapy.

Recent technological advances in fiber optics, light sources, detectors, and molecular biology have stimulated development of numerous optical methods that promise to significantly improve our ability to evaluate human epithelium in vivo. These methods, collectively termed "optical biopsy," are nondestructive in situ assays of mucosal histopathology using light that can provide instantaneous tissue assessment. Narrow band imaging (NBI) is a novel technique that enhances the diagnostic capability of endoscopes in characterising tissues by using filters in a redgreenblue (RGB) sequential illumination system. This results in improved mucosal contrast and detail.

UC always involves the distal colon and activity is usually greatest in rectosigmoid area. This makes evaluation of the rectum and sigmoid an attractive marker in patients with UC. Unlike serum and faecal markers, endoscopic assessment of the mucosa is unlikely to be affected by systemic disease and would be acceptable test for patients and physicians.

We plan to evaluate THE rectosigmoid mucosa in patients with UC by flexible endoscope using both white light and NBI endoscopy. These patients will be followed by for one year or until they relapse, whichever comes first. The aim of our study is to develop endoscopic biomarkers to predict relapse in acute and quiescent UC.

02

Conditions studied

  • Ulcerative Colitis (UC)
03

In context

Colitis

1,073 studies on the registry are indexed under Colitis; 131 are open to participants now.

Browse Colitis studies →

Lead sponsor

The Leeds Teaching Hospitals NHS Trust is the lead sponsor of 95 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All

Inclusion criteria

  • Adult patients referred for lower gastrointestinal endoscopy procedure will be recruited.
  • Any age (1885 years), gender or ethnic background
  • Able and willing to give an informed consent

Exclusion criteria

Exclusion Criteria:

  • Patients known to be intolerant to endoscopy.
  • Patients with severe lifethreatening comorbidity as judged by the investigator.
  • Patients on therapy with anticoagulation that may preclude taking any biopsies
  • Pregnant women or breast feeding mothers
  • Patient with toxic megacolon
  • patients on medications known to cause bowel inflammation.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)

Study arms

  • Experimental
    NBI

    Procedure: NBI

Interventions

  • ProcedureNBI
06

What researchers measure

Primary outcomes

  1. Narrow band imaging (NBI)

    Time frame: up to 2 years

07

Study locations

1 of 1 sites recruiting
  • Leeds Teaching Hospital NHS Trust
    Leeds, LS9 7TF, United Kingdom
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 19, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02049775
Lead sponsor
The Leeds Teaching Hospitals NHS Trust
Responsible party
Sponsor
First posted
Jan 30, 2014
Start date
Apr 2013
Primary completion
Apr 2015
Last update
Feb 19, 2016

Study contacts

Venkataraman Subramanian, MD, MRCP
Contact
venkat.subramanian@leedsth.nhs.uk
01132068822
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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