NCT00292175

Brief Summary

The purpose of the study is to determine whether a new colonoscopic viewing technique called narrow band imaging (NBI) helps doctors detect more patients with at leat one pre-cancerous area (dysplasia associated lession or mass, MALMs) than conventional colonoscopy using white light alone.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

February 14, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 15, 2006

Completed
Last Updated

September 24, 2007

Status Verified

September 1, 2007

First QC Date

February 14, 2006

Last Update Submit

September 21, 2007

Conditions

Ulcerative Colitis

Keywords

colonoscopy, narrow band imaging (NBI), ulcerative colitis

Outcome Measures

Primary Outcomes (1)

  • Effectiveness of NBI versus Light endoscopy

Secondary Outcomes (4)

  • Are more precancerous lessions found in total with NBI?

  • Are more advanced precancerous lesions found with NBI?

  • Are more patients found with more that one precancerous lesion with NBI?

  • How Many lessions are successfully completely removed via the endoscope?

Interventions

Narrow Band ImagingPROCEDURE
colonoscopyPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • petients with colitis who meet surveillance criteria
  • patients over 18 years of age

You may not qualify if:

  • pregnant patients
  • unable or unwilling to give informed consent
  • patients with severe active colitis who would be unsafe to endoscope

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

North West London Hospitals NHS Trust - St Mark's

London, Middlesex, HA1 3UJ, United Kingdom

RECRUITING

Nottingham Univesrity Hospitals NHS Trust, Queen's Medical Centre

Nottingham, NG7 2UH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Narrow Band ImagingColonoscopy

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Optical ImagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesEndoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Brian Saunders, MD, FRCP

    London North West Healthcare NHS Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Brian Saunders, MD, FRCP

CONTACT

0044208235b.saunders@imperial.ac.uk

James East, BSc, MBChB, MRCP

CONTACT

0044208235jameseast@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 14, 2006

First Posted

February 15, 2006

Study Start

February 1, 2006

Last Updated

September 24, 2007

Record last verified: 2007-09

Locations

GB(2)