NCT04837599

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,100 (estimated)
• Sponsor: Gastroenterologie Baden-Wettingen · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Colonic Polyp
• Adenoma

Interventions

Type	Name	Description
DEVICE	Discovery TM of Pentax medical on/off in colonoscopy	on the monitor artificial integlligence Discovery can be switched on or off.

Timeline

• Start date: 2021-08-01
• Primary completion: 2022-07-31
• Completion: 2022-10-31
• First posted: 2021-04-08
• Last updated: 2021-04-19

Locations

1 site across 1 country: Switzerland