Artificial Intelligence Performance in Colonoscopy in Daily Practice

April 13, 2021 updated by: Geyer Martin, Gastroenterologie Baden-Wettingen

Artificial Intelligence Performance in Colonoscopy in Daily Practice: Randomised, Comparative Study of Pentax i10 Colonoscopes With or Without Endocuff Combined With Discovery™ or Without

randomized, controlled single center, single investigator study mainly in colorectal screening population in daily practice with and without artificial intelliegence (AI) named DiscoveryTM from Pentax medical. Patient randomly are allocated to one of four groups: Pentax i10 colonoscopes without any additional device, Pentax i 10 with DiscoveryTM (AI), Pentax i 10 with EndocuffTM and Pentax i10 with EndocuffTM and DiscoveryTM (AI).

The different groups are compared in terms of the different parameters: e.g. time of endoscopy, polyps (PDR) and adenoma detected (ADR).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

From August 2021 through August 2022 all patients undergoing a colonoscopy in a gastroenterologist's private practice are assigned using randomization tables to one or the other above mentioned groups. Time of the endoscopy (ascent, descent and intervention time), polyps detected and their histology are written down real time with a tablet computer anonymized with the patient number. Furthermore dosage of sedatives and over all satisfaction is traced.

  1. endpoint is time gain in the different phase of the colonoscopy
  2. endpoint is adenoma detection rate (ADR)

Study Type

Interventional

Enrollment (Anticipated)

1100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Aargau
      • Wettingen, Aargau, Switzerland, 5430
        • Martin Geyer
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • all patients referred and fit for an ambulant colonoscopy

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Pentax i 10
Patient gets normal colonoscopy without Endocuff or activation of artifical intelligence
Active Comparator: Pentax i 10 with artificial intelligence Discovery TM
Normal Pentax i 10 colonoscope with on the special monitor acitvated artificial intelligence
Device: Discovery TM of Pentax medical on/off in colonoscopy
on the monitor artificial integlligence Discovery can be switched on or off.
Other Names:
  • Endocuff mounted yes/no
Active Comparator: Pentax i 10 with Endocuff TM
Endocuff cap is mounted on the tip of the endoscope a cheap assistance device proven in former studies to increase adenoma detection rate.
Device: Discovery TM of Pentax medical on/off in colonoscopy
on the monitor artificial integlligence Discovery can be switched on or off.
Other Names:
  • Endocuff mounted yes/no
Active Comparator: Pentax i 10 with Endocuff TM and artificial intelligence Discovery TM
Endocuff cap is mounted on the tip of the endoscope and artificial intelligence is activated on the monitor. hypothesis is that probably artificial intelligence and Endocuff combined potentiate their effect.
Device: Discovery TM of Pentax medical on/off in colonoscopy
on the monitor artificial integlligence Discovery can be switched on or off.
Other Names:
  • Endocuff mounted yes/no

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endoscopy time
Time Frame: within 45 minutes of examination
measurement of ascent, descent and intervention time during colonoscopy
within 45 minutes of examination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
polyp and adenoma detetction rate PDR and ADR
Time Frame: within 45 minutes of examination
counts of polypes and their location in the colon and their histology
within 45 minutes of examination

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medication dosage
Time Frame: withn 45 minutes of examination
Dosage of Propofol and Buscopan
withn 45 minutes of examination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gastroenterologie Baden-Wettingen

Collaborators

Ludwig-Maximilians - University of Munich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2021

Primary Completion (Anticipated)

July 31, 2022

Study Completion (Anticipated)

October 31, 2022

Study Registration Dates

First Submitted

April 6, 2021

First Submitted That Met QC Criteria

April 6, 2021

First Posted (Actual)

April 8, 2021

Study Record Updates

Last Update Posted (Actual)

April 19, 2021

Last Update Submitted That Met QC Criteria

April 13, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Gastro BW 1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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