NCT05006092

Brief Summary

Evaluation of an artificial intelligence system for polyp detection (CADe)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,149

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2021

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

First Submitted

Initial submission to the registry

June 11, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 16, 2021

Completed
16 days until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
Last Updated

April 27, 2023

Status Verified

April 1, 2023

Enrollment Period

1.2 years

First QC Date

June 11, 2021

Last Update Submit

April 26, 2023

Conditions

Surveillance Endoscopy for Colorectal CancerArtificial IntelligencePolyps of ColonCADe

Outcome Measures

Primary Outcomes (1)

  • adenoma detection rate

    proportion of individuals undergoing a complete screening colonoscopy who have one or more adenomas

    4 months

Secondary Outcomes (4)

  • polyp detection rate

    4 months

  • withdrawal time

    4 months

  • resection time

    4 months

  • Boston Bowl Preparation Score

    4 months

Study Arms (2)

surveillance endoscopy with CADe support

EXPERIMENTAL

Endoscopy perfomed with CADe support.

Device: ENDOMIND

conventional surveillance endoscopy

NO INTERVENTION

Endoscopy perfomed without CADe support.

Interventions

ENDOMINDDEVICE

CADe system for Polyp detection

surveillance endoscopy with CADe support

Eligibility Criteria

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

You may qualify if:

  • indication CRC surveillance endoscopy
  • indication post-polypectomy surveillance endoscopy
  • positive fecal immunochemical test in patients \>=50 years

You may not qualify if:

  • reasonable suspicion of inflammatory bowl disease
  • reasonable suspicion of familiar polyposis Syndrome
  • Patient after radiation/resection of colonic parts

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsklinikum Würzburg

Würzburg, Bavaria, 97080, Germany

Location

Related Publications (1)

  • Lux TJ, Banck M, Sassmannshausen Z, Troya J, Krenzer A, Fitting D, Sudarevic B, Zoller WG, Puppe F, Meining A, Hann A. Pilot study of a new freely available computer-aided polyp detection system in clinical practice. Int J Colorectal Dis. 2022 Jun;37(6):1349-1354. doi: 10.1007/s00384-022-04178-8. Epub 2022 May 11.

    PMID: 35543874DERIVED

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Alexander Hann

    Wuerzburg University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2021

First Posted

August 16, 2021

Study Start

September 1, 2021

Primary Completion

November 30, 2022

Study Completion

November 30, 2022

Last Updated

April 27, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)