Artificial Intelligence Performance in Colonoscopy in Daily Practice

NCT ID: NCT04837599

Last Updated: 2021-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-01

Study Completion Date

2022-10-31

Brief Summary

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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).

Detailed Description

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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)

Conditions

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Colonic Polyp Adenoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Pentax i 10

Patient gets normal colonoscopy without Endocuff or activation of artifical intelligence

Group Type NO_INTERVENTION

No interventions assigned to this group

Pentax i 10 with artificial intelligence Discovery TM

Normal Pentax i 10 colonoscope with on the special monitor acitvated artificial intelligence

Group Type ACTIVE_COMPARATOR

Discovery TM of Pentax medical on/off in colonoscopy

Intervention Type DEVICE

on the monitor artificial integlligence Discovery can be switched on or off.

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.

Group Type ACTIVE_COMPARATOR

Discovery TM of Pentax medical on/off in colonoscopy

Intervention Type DEVICE

on the monitor artificial integlligence Discovery can be switched on or off.

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.

Group Type ACTIVE_COMPARATOR

Discovery TM of Pentax medical on/off in colonoscopy

Intervention Type DEVICE

on the monitor artificial integlligence Discovery can be switched on or off.

Interventions

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Discovery TM of Pentax medical on/off in colonoscopy

on the monitor artificial integlligence Discovery can be switched on or off.

Intervention Type DEVICE

Other Intervention Names

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Endocuff mounted yes/no

Eligibility Criteria

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Inclusion Criteria

* all patients referred and fit for an ambulant colonoscopy

Exclusion Criteria

* none
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role collaborator

Gastroenterologie Baden-Wettingen

OTHER

Sponsor Role lead

Responsible Party

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Geyer Martin

Dr med. Geyer Martin, Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Martin Geyer

Wettingen, Canton of Aargau, Switzerland

Site Status

Countries

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Switzerland

Facility Contacts

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Martin Geyer, MD

Role: primary

0562227292

Other Identifiers

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Gastro BW 1

Identifier Type: -

Identifier Source: org_study_id

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