Artificial Intelligence in Colonic Polyp Detection | NCT05178095

Studies
Artificial Intelligence in Colonic Polyp Detection

NCT05178095

Sponsor

Sahlgrenska University Hospital

Status

Completed

Last Update Posted

Jun 28, 2023Actual

Enrollment

250Actual

Phase

Not Applicable

Conditions

Polyp of Colon
Adenoma Colon
Gastrointestinal Neoplasms

Interventions

Artificial intelligence
No Artificial Intelligence

Countries

Sweden

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

Jun 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 30, 2020Actual

Primary Completion Date

Jun 1, 2023Actual

Completion Date

Jun 1, 2023Actual

First Submitted Date

Nov 15, 2021

First Submission Date that Met QC Criteria

Dec 15, 2021

First Posted Date

Jan 5, 2022Actual

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

Jun 27, 2023

Last Update Posted Date

Jun 28, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Per Hedenström, Principal Investigator, Sahlgrenska University HospitalPrincipal Investigator

Lead Sponsor

Sahlgrenska University HospitalOTHER

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

A randomized, controlled study investigating the potential benefits of artificial intelligence (AI) in the detection of colonic polyps during outpatient colonoscopy. Randomization between the use of AI and no AI is performed before the study procedure.

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

250Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AI	Experimental	Colonoscopy with AI	Device: Artificial intelligence
No AI	Placebo Comparator	Colonoscopy without AI	Device: No Artificial Intelligence

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Artificial intelligence	Device	Colonoscopy with the aid of artificial intelligence for the detection of colonic polyps	AI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
ADR	Adenoma detection rate	1 hour

Secondary Outcomes

Measure	Description	Time Frame
APC	Adenomas per colonoscopy	1 hour
Procedural time	The number of minutes required to complete the colonoscopy withdrawal	1 hour

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients without IBD referred for colonoscopy

Exclusion Criteria:

Age < 40 years
Not willing to participate

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Björn Lindkvist	Sahlgrenska University Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dr Per Hedenström		Gothenburg		S-413 45	Sweden

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38290758	Derived	Scholer J, Alavanja M, de Lange T, Yamamoto S, Hedenstrom P, Varkey J. Impact of AI-aided colonoscopy in clinical practice: a prospective randomised controlled trial. BMJ Open Gastroenterol. 2024 Jan 30;11(1):e001247. doi: 10.1136/bmjgast-2023-001247.

ID	Term
D003111	Colonic Polyps
D005770	Gastrointestinal Neoplasms

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