NCT03069833

Brief Summary

An NBI-based diagnosis requires training and experience. We are developing a system of computerized image recognition, which can detect possible NBI features of polyps, and provide a more objective diagnosis, which allows nonexpert endoscopists to achieve a high diagnostic accuracy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

February 28, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

March 1, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 3, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

March 28, 2017

Status Verified

March 1, 2017

Enrollment Period

9 months

First QC Date

February 28, 2017

Last Update Submit

March 25, 2017

Conditions

Colon Polyp

Outcome Measures

Primary Outcomes (1)

  • Sensitivity, Specificity, False Positive, False Negative

    Diagnostic accuracy

    Duration between endoscopic diagnosis and pathologic diagnosis is about one week

Study Arms (2)

Computer-aided diagnosis

EXPERIMENTAL
Diagnostic Test: Computer-aided diagnosis

traditional diagnosis

NO INTERVENTION

Interventions

Computer-aided diagnosisDIAGNOSTIC_TEST

computer-aided diagnosis to assist colonoscopists

Computer-aided diagnosis

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • the same as colonoscopy

You may not qualify if:

  • the same as colonoscopy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Endoscopy Center, Tri-Service General Hospital

Taipei, 114, Taiwan

RECRUITING

MeSH Terms

Conditions

Colonic Polyps

Interventions

Diagnosis, Computer-Assisted

Condition Hierarchy (Ancestors)

Intestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnosis

Study Officials

  • Peng-Jen Chen, MD

    Tri-Service General Hospital, National Defense Medical Center, Taiwan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Peng-Jen Chen, MD

CONTACT

+886-87923311endoscopy@ndmctsgh.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Endoscopy Center

Study Record Dates

First Submitted

February 28, 2017

First Posted

March 3, 2017

Study Start

March 1, 2017

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

March 28, 2017

Record last verified: 2017-03

Locations

TW(1)