CADDIE Trial - Computer Aided Diagnosis and Detection for Intelligent Endoscopy

Colorectal Polyp Clinical Trial

— CADDIE  

Official title:

Multi-Centre, Open-label, Randomised, Prospective Trial to Assess Efficacy and Safety of the CADDIE Artificial Intelligence System for Improving Endoscopic Detection of Colonic Polyps in Real-time.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04325815
• Other study ID #: 126166
• Status: Active, not recruiting
• Start date: April 29, 2021
• Est. completion date: November 2023

Study information

• Verified date: May 2023
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Background:

Colonoscopy is accepted to be the gold standard for screening of colorectal cancer (CRC). Most CRCs develop from adenomatous polyps, with colonoscopy accepted to be the gold standard for screening of CRC. An endoscopist's ability to detect polyps is assessed in the form of an Adenoma Detection Rate (ADR). Each 1.0% increase in ADR is associated with a 3.0% decrease in the risk of the patient developing an interval CRC. There remains a wide variation in endoscopist ADR.

More recently, the use of artificial intelligence (AI) and computer aided diagnosis in endoscopy has been gaining increasing attention for its role in automated lesion detection and characterisation. AI can potentially improve ADR, but previous AI related work has largely focused on retrospectively assessing still endoscopic images and selected video sequences which may be subject to bias and lack clinical utility. There are only limited clinical studies evaluating the effect of AI in improving ADR.

The CADDIE device uses convolutional neural networks developed for computer assisted detection and computer assisted diagnosis of polyps.

Primary objective: To determine whether the CADDIE artificial intelligence system improves endoscopic detection of adenomas during colonoscopy.

Primary endpoint: The difference in adenoma detection rate (ADR) between the intervention (supported with the CADDIE system) and non-intervention arm

Study design: Multi-Centre, open-label, randomised, prospective trial to assess efficacy and safety of the CADDIE artificial intelligence system for improving endoscopic detection of colonic polyps in real-time.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 654
• Est. completion date: November 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient's scheduled to undergo a surveillance or symptomatic colonoscopy with an endoscopist participating in the study phase of the trial.

• Male and female participants aged 18 years or older at the time of informed consent.

• Patient's able to comprehend, sign and date the written informed consent document to participate in the study.

Exclusion Criteria:

• Emergency colonoscopies and/or inpatient colonoscopies.

• Patients with inflammatory bowel disease (IBD)

• Patients with Colorectal Cancer (CRC)

• Patients with previous CRC

• Patients with previous colonic resection

• Patients returning for a planned elective therapeutic colonoscopy.

• Polyposis syndromes

• Current or relevant history of a physical or psychiatric illness or any medical condition that in the opinion of the investigator could affect the patient's safety or interfere with the study assessments

• Patients with a contraindication for biopsy or polypectomy. These include:

• Patients who have not withheld medications pre-disposing to bleeding at time of colonoscopy as per local site /national guidelines 30.

• Patients with a history of haemostasis disorders (Haemostasis disorders will include but will not be limited to: patients with haemophilia or other congenitally acquired clotting factor deficiencies, patients with cirrhosis with coagulopathy, patients known to have thrombocytopenia (<80,000 platelet/ul) and individuals with Von Willebrand's disease or other known platelet malfunction disorders).

• Patients is enrolled in another research study with an investigational medicinal product (IMP) or non-IMP that pre-disposes them to bleeding

Related Conditions & MeSH terms

• Adenoma
• Adenoma Colon
• Colon Polyp
• Colorectal Polyp
• Polyps

Intervention

Device:
• CADDIE- Computer Aided (AI) Device used in Endoscopy
CADDIE assisted polyp detection CADDIE assisted polyp characterisation

Locations

Country	Name	City	State
United Kingdom	University College London	London

Sponsors (1)

Lead Sponsor	Collaborator
University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate whether using the CADDIE system improves endoscopist detection of adenomas during colonoscopy.	The difference in endoscopist ADR between the intervention (CADDIE system) and non-intervention arm.	3 years
Secondary	Evaluate the difference in number of adenomas detected per colonoscopy between intervention and non-intervention arm	Compare the difference in the number of adenomas detected per colonoscopy between the intervention and non-intervention arm	3 years
Secondary	To determine whether the CADDIE artificial intelligence system improves endoscopic detection of all polyps during colonoscopy	Polyp Detection Rate (including proximal polyp detection rate) in the interventional group compared to the control group.; - Mean number of polyps detected per colonoscopy in the interventional group compared to the control group.	3 years
Secondary	Compare the accuracy of endoscopist optical diagnosis of diminutive polyps when using the CADDIE system (intervention arm) compared to without the CADDIE system (control arm)	Compare the accuracy of CADDIE against human endoscopist (high confidence diagnoses) for the optical diagnosis of diminutive polyps.	3 years
Secondary	Compare the accuracy of endoscopist optical diagnosis to assign colonoscopy surveillance intervals when using the CADDIE system (intervention arm) compared to without the CADDIE system (control arm)	Compare the accuracy of using CADDIE's optical diagnosis to assign surveillance colonoscopy intervals against using human endoscopist optical diagnosis (high confidence diagnoses) for assigning surveillance colonoscopy intervals.	3 years
Secondary	Compare the accuracy of endoscopist optical diagnosis of diminutive rectal polyps when using the CADDIE system (intervention arm) compared to without the CADDIE system (control arm)	Compare the accuracy of CADDIE against human endoscopist (high confidence diagnoses) for the optical diagnosis of diminutive rectal polyps.	3 years
Secondary	Evaluate the safety of the CADDIE by recording occurrence and severity of adverse events.	Safety of the device will be assessed through monitoring of adverse events for 30 days' post-procedure. Adverse events are defined as: Abdominal pain/discomfort.; Abdominal bloating.; Sedation related aspiration.; Bleeding risk.; Perforation.; Post polypectomy electrocoagulation syndrome.; Infection.	3 years
Secondary	Assess integration of CADDIE into normal colonoscopy clinical workflow.	- Endoscopist/endoscopy nurse/patient experience and acceptability of the CADDIE system assessed by qualitative questionnaire.	3 years