Application of AI in Polypectomy | NCT04485715

Studies
Application of AI in Polypectomy

NCT04485715

Sponsor

Yanqing Li

Status

Unknown status

Last Update Posted

Jul 24, 2020Actual

Enrollment

1,000Estimated

Phase

Not Applicable

Conditions

Colonic Polyp

Interventions

AI system

Countries

China

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

Jul 2020

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

Jul 21, 2020Estimated

Primary Completion Date

Jul 21, 2021Estimated

Completion Date

Sep 21, 2021Estimated

First Submitted Date

Jul 14, 2020

First Submission Date that Met QC Criteria

Jul 23, 2020

First Posted Date

Jul 24, 2020Actual

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

Jul 23, 2020

Last Update Posted Date

Jul 24, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

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

1,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AI-aided group	Experimental		Other: AI system
control group	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AI system	Other	The real-time assistance of AI system	AI-aided group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
polypectomy time	the time for detection in polypectomy	12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

to undergo colorectal polypectomy;
agree to give written informed consent

Exclusion Criteria:

patients with the contraindications to colorectal polypectomy;
patients with a history of inflammatory bowel disease (IBD), CRC, colorectal surgery;
patients with high suspicion of polyposis syndromes, IBD and typical advanced CRC;
patients refused to participate in the trial;
the procedure cannot be completed due to stenosis, obstruction, huge occupying lesions, or solid stool;
the procedure have to be terminated due to complications of anaesthesia.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yanqing Li, PhD, MD	Contact	86-531-82166095		liyanqing@sdu.edu.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Gastroenterology, Qilu Hospital, Shandong University	Recruiting	Jinan	Shandong		China

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
D000098403	Intelligent Systems

Ancestor Terms

ID	Term
D001185	Artificial Intelligence
D000465	Algorithms
D055641	Mathematical Concepts

Browse Leaves

Not provided

Browse Branches

Not provided