Artificial Intelligence Performance in Colonoscopy in Daily Practice

Not Applicable

• Conditions: Colonic Polyp; Adenoma
• Interventions: Device: Discovery TM of Pentax medical on/off in colonoscopy

• Registration Number: NCT04837599
• Lead Sponsor: Gastroenterologie Baden-Wettingen

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)

Study Timeline

• Status Verified: 2021-04
• Study First Submitted: 2021-04-06
• Study First Submitted QC: 2021-04-06
• Study First Posted: 2021-04-08
• Last Update Submitted: 2021-04-13
• Last Update Posted: 2021-04-19
• Study Start: 2021-08-01
• Primary Completion: 2022-07-31
• Study Completion: 2022-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1100

Inclusion Criteria

• all patients referred and fit for an ambulant colonoscopy

Exclusion Criteria

• none

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pentax i 10 with Endocuff TM	Discovery TM of Pentax medical on/off in colonoscopy	Endocuff cap is mounted on the tip of the endoscope a cheap assistance device proven in former studies to increase adenoma detection rate.
Pentax i 10 with artificial intelligence Discovery TM	Discovery TM of Pentax medical on/off in colonoscopy	Normal Pentax i 10 colonoscope with on the special monitor acitvated artificial intelligence
Pentax i 10 with Endocuff TM and artificial intelligence Discovery TM	Discovery TM of Pentax medical on/off in colonoscopy	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.

Primary Outcome Measures

Name	Time	Method
Endoscopy time	within 45 minutes of examination	measurement of ascent, descent and intervention time during colonoscopy

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Martin Geyer; 🇨🇭 Wettingen, Aargau, Switzerland