NCT04359355

Brief Summary

In this observational pilot study, we assess the diagnostic performance of an artificial intelligence sytem for automated detection of colorectal polyps.

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
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

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

Study Start

First participant enrolled

January 1, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 24, 2020

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2020

Completed
Last Updated

April 24, 2020

Status Verified

April 1, 2020

Enrollment Period

4 months

First QC Date

April 21, 2020

Last Update Submit

April 21, 2020

Conditions

Keywords

colonoscopyendoscopyadenoma detectionpolyp detectionartificial intelligence

Outcome Measures

Primary Outcomes (1)

  • Feasibility to use the AI System in vivo during colonoscopy

    As a Primary outcome, whether the AI System is capable of detecting colorectal polyps in vivo during colonoscopy

    4 month

Secondary Outcomes (1)

  • Diagnostic Performance of the AI System for detecting colorectal polyps

    4 month

Study Arms (1)

Artificial Intelligence

Device: Artificial Intelligence System for Detection of colorectal polyps

Interventions

In this group, an artificial Intelligence System will be used for computer-aided diagnosis of colorectal polyps. Diagnostic Performance of the artificial intelligence System for detection of polyps will be compared against Operator-based detection in the same group

Artificial Intelligence

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients presenting between January and May 2020 for surveillance or Screening colonoscopy in the Ludwig Demling Endoscopy Center of Excellence will be prospectively included under the above mentioned inclusion and exclusion criteria. Prior to enrollment, written informed consent will be obtained.

You may qualify if:

  • Screening or surveillance colonoscopy

You may not qualify if:

  • known or suspected inflammatory bowel disease
  • uncontrolled coagulopathy
  • known polyps or referral for polypectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Erlangen

Erlangen, 91054, Germany

RECRUITING

Related Publications (1)

  • Pfeifer L, Neufert C, Leppkes M, Waldner MJ, Hafner M, Beyer A, Hoffman A, Siersema PD, Neurath MF, Rath T. Computer-aided detection of colorectal polyps using a newly generated deep convolutional neural network: from development to first clinical experience. Eur J Gastroenterol Hepatol. 2021 Dec 1;33(1S Suppl 1):e662-e669. doi: 10.1097/MEG.0000000000002209.

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Endoscopy

Study Record Dates

First Submitted

April 21, 2020

First Posted

April 24, 2020

Study Start

January 1, 2020

Primary Completion

April 30, 2020

Study Completion

May 31, 2020

Last Updated

April 24, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

The study will be published in scientific magazines after competion and thus will be made available to other Researchers. Individual Patient data will not be displayed or shared.

Locations