Improving Polyp Detection Rate by Artificial Intelligence in Colonoscopy

Colonic Polyp Clinical Trial

Official title:

Improving Polyp Detection Rate by Artificial Intelligence in Colonoscopy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05322993
• Other study ID #: REK 275068
• Status: Recruiting
• Phase: N/A
• Start date: November 19, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2023
• Source: Haraldsplass Deaconess Hospital
• Contact: Tom André Pedersen, MD
• Phone: 95812371
• Email: tom_andre_pedersen[@]haraldsplass.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to investigate if the use of artificial intelligence (AI) in colonoscopy improves the polyp detection rate, and if the use of AI has a learning effect.

Description:

The endoscopists will use GI Genius from Medtronic, a device that uses artificial intelligence (AI) based on machine learning to detect polyps in the colon in real time during colonoscopy. The device interprets the endoscopy pictures and superimposes possible polyps with frames.

The patients will be included in regular outpatient clinics in Western Norway. The endoscopists will be divided into groups depending on their experience. The endoscopists will perform colonoscopies in three phases; (1) before the use of AI, (2) during the use of AI and (3) after the use of AI. The investigators will then evaluate the polyp detection rate (PDR) in the three phases to see if AI increases PDR, and if there is a learning effect on PDR after the use of AI. The investigators will also evaluate if there is a difference in the learning-effect from AI-use depending on if the endoscopist is experienced or inexperienced.

The PDR's are registered as part of Norway's national quality register of colonoscopy, Gastronet. The data registered in Gastronet can also help the investigators evaluate other outcomes such as withdrawal time, bowel preparation, patient reported pain, patient satisfaction and complications.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4500
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients coming to outpatient clinics to perform colonoscopies

Exclusion Criteria:

• Total colectomy

• Reservation against registration in Gastronet, the national quality register for colonoscopy in Norway

Related Conditions & MeSH terms

• Colonic Polyp
• Colonic Polyps
• Polyps

Intervention

Device:
• GI Genius
The use of artificial intelligence during colonoscopy to improve polyp detection.
• Standard white light colonoscope
Standard colonoscopy.

Locations

Country	Name	City	State
Norway	Haraldsplass Deaconess Hospital	Bergen	Vestland
Norway	Haukeland University Hospital	Bergen	Vestland
Norway	Kanalspesialistene AS	Bergen	Vestland

Sponsors (4)

Lead Sponsor	Collaborator
Haraldsplass Deaconess Hospital	European Society of Gastrointestinal Endoscopy, Haukeland University Hospital, Kanalspesialistene AS

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Polyp detection rate (PDR) with and without artificial intelligence (AI)	Evaluate the PDR with and without the use of GI Genus artificial intelligence	18 months
Primary	PDR after the use of AI, is there a learning effect?	Evaluate if there is an improved PDR after the use of AI	18 months
Secondary	Withdrawal time	To evaluate if the withdrawal time is influenced by the use of artificial intelligence	18 months
Secondary	Complications	To evaluate if there are more registered complications with the use of AI	24 months

External Links

•   Gastronet, the national quality register of colonoscopies