Computer Aided Diagnosis of Colorectal Neoplasms During C... | NCT03069833

Studies
Computer Aided Diagnosis of Colorectal Neoplasms During Colonoscopic Examination

NCT03069833

Sponsor

Tri-Service General Hospital (TSGH)

Status

Unknown status

Last Update Posted

Mar 28, 2017Actual

Enrollment

300Estimated

Phase

Not Applicable

Conditions

Colon Polyp

Interventions

Computer-aided diagnosis

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2017Actual

Primary Completion Date

Dec 2017Estimated

Completion Date

Dec 2017Estimated

First Submitted Date

Feb 28, 2017

First Submission Date that Met QC Criteria

Feb 28, 2017

First Posted Date

Mar 3, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 25, 2017

Last Update Posted Date

Mar 28, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Peng-Jen Chen, Head of Endoscopy Center, Tri-Service General Hospital (TSGH)Principal Investigator

Lead Sponsor

Tri-Service General Hospital (TSGH)OTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Computer-aided diagnosis	Experimental		Diagnostic Test: Computer-aided diagnosis
traditional diagnosis	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Computer-aided diagnosis	Diagnostic Test	computer-aided diagnosis to assist colonoscopists	Computer-aided diagnosis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sensitivity, Specificity, False Positive, False Negative	Diagnostic accuracy	Duration between endoscopic diagnosis and pathologic diagnosis is about one week

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

the same as colonoscopy

Exclusion Criteria:

the same as colonoscopy

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Peng-Jen Chen, MD	Contact	+886-87923311	88056	endoscopy@ndmctsgh.edu.tw

Overall Officials

Name	Affiliation	Role
Peng-Jen Chen, MD	Tri-Service General Hospital, National Defense Medical Center, Taiwan	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Endoscopy Center, Tri-Service General Hospital	Recruiting	Taipei		114	Taiwan

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003111	Colonic Polyps

Ancestor Terms

ID	Term
D007417	Intestinal Polyps
D011127	Polyps
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003936	Diagnosis, Computer-Assisted

Ancestor Terms

ID	Term
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided