NCT03118856

Brief Summary

To assess the accuracy of predicting histology of colorectal polyps with electronic chromoendoscopy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
230

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 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

February 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 18, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2018

Completed
Last Updated

September 26, 2019

Status Verified

September 1, 2019

Enrollment Period

1.1 years

First QC Date

April 13, 2017

Last Update Submit

September 25, 2019

Conditions

Colorectal Polyp

Outcome Measures

Primary Outcomes (1)

  • Accuracy of predicting histology with EC

    Polyps will be visualized in white-light and the location and size will be noted. Afterwards, electronic chromoendoscopy will be used to visualize and enhance the mucosal vascular pattern and the mucosal surface pattern morphology of the polyp. The endoscopist will then make a real time assessment of each polyp according to size, shape, Paris classification and surface characteristics including pit pattern and mucosal vascular pattern morphology, colour, and type of depression. Further, a level of confidence (high or low) will be made for the real time histology prediction. Finally, all polyps will be removed using standard techniques and processed for pathological evaluation and real time and histological results will be compared.

    1 year

Study Arms (2)

HD-WLE

Intervention: Prediction of polyp histology with HD-WLE

Diagnostic Test: Prediction of Histology

EC

Intervention: Prediction of polyp histology with EC

Diagnostic Test: Prediction of Histology

Interventions

Prediction of HistologyDIAGNOSTIC_TEST

The accuracy of predicting the histology of colorectal polyps will be assessed with HD-WLE and EC

ECHD-WLE

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing screening or surveillance colonoscopy

You may qualify if:

  • patients undergoing screening or surveillance colonoscopy
  • written informed consent

You may not qualify if:

  • inadequate bowel preparation
  • polyposis syndromes
  • history of colectomy
  • use of anticoagulants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Erlangen

Erlangen, 91054, Germany

Location

Study Officials

  • Timo Rath, MD

    University Hospital Erlangen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2017

First Posted

April 18, 2017

Study Start

February 1, 2017

Primary Completion

February 28, 2018

Study Completion

May 31, 2018

Last Updated

September 26, 2019

Record last verified: 2019-09

Locations

DE(1)