Artificial Intelligence Performance in Colonoscopy in Daily Practice

Colonic Polyp Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04837599
• Other study ID #: Gastro BW 1
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: October 31, 2022

Study information

• Verified date: April 2021
• Source: Gastroenterologie Baden-Wettingen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1100
• Est. completion date: October 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• all patients referred and fit for an ambulant colonoscopy

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Adenoma
• Colonic Polyp
• Colonic Polyps

Intervention

Device:
• Discovery TM of Pentax medical on/off in colonoscopy
on the monitor artificial integlligence Discovery can be switched on or off.

Locations

Country	Name	City	State
Switzerland	Martin Geyer	Wettingen	Aargau

Sponsors (2)

Lead Sponsor	Collaborator
Gastroenterologie Baden-Wettingen	Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Medication dosage	Dosage of Propofol and Buscopan	withn 45 minutes of examination
Primary	Endoscopy time	measurement of ascent, descent and intervention time during colonoscopy	within 45 minutes of examination
Secondary	polyp and adenoma detetction rate PDR and ADR	counts of polypes and their location in the colon and their histology	within 45 minutes of examination