Artificial Intelligence Performance in Colonoscopy in Daily Practice

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04837599

Enrollment

1100

Registered

2021-04-08

Start date

2021-08-01

Completion date

2022-10-31

Last updated

2021-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenoma, Colonic Polyp

Keywords

artificial intelligence

Brief summary

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

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)

Interventions

DEVICEDiscovery TM of Pentax medical on/off in colonoscopy

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

15 Years to No maximum

Healthy volunteers

Inclusion criteria

* all patients referred and fit for an ambulant colonoscopy

Exclusion criteria

* none

Design outcomes

Primary

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

Secondary

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

Other

Measure	Time frame	Description
Medication dosage	withn 45 minutes of examination	Dosage of Propofol and Buscopan

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026