CADDIE Trial - Computer Aided Diagnosis and Detection for Intelligent Endoscopy

Browse trials for

• Polyps 389
• Colonic Polyps 326

Keywords

• Artificial Intelligence
• Endoscopy
• ADR

Polyps

389 studies on the registry are indexed under Polyps; 59 are open to participants now.

This study's enrollment of 739 is above the median of 272 across 129 observational studies indexed under Polyps.

Lead sponsor

University College, London is the lead sponsor of 647 studies on the registry; 145 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.

Study population

Groups and cohorts

• CADDIE

  The endoscopist will be assisted with CADDIE system to detect polyps. The endoscopist will perform optical diagnosis of polyps with the assistance of the CADDIE's polyp characterisation function.

  Device: CADDIE- Computer Aided (AI) Device used in Endoscopy

• Standard Procedure

  In addition to routine colonoscopy the endoscopist will perform optical diagnosis of detected polyps without the assistance of the CADDIE.

Interventions

• DeviceCADDIE- Computer Aided (AI) Device used in Endoscopy

  1. CADDIE assisted polyp detection 2. CADDIE assisted polyp characterisation

Primary outcomes

1. 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.

   Time frame: 30 days

Secondary outcomes

1. 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

   Time frame: 30 days

2. 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.

   Time frame: 30 days

3. 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. Accuracy is defined as true positive and true negative divided by diagnoses total polyps that were optically diagnosed with high confidence.

   Time frame: 30 days

4. 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.

   Time frame: 30 days

5. 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.

   Time frame: 30 days

6. 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.

   Time frame: 30 days

7. Assess Patient Anxiety During the Colonoscopy

   Patient response to the question 'How anxious or calm were you during the colonoscopy?' assessed by Likert Scale with 5 options - 1 (Very anxious), 2 (Somewhat anxious), 3 (Neither Anxious nor calm), 4 (Somewhat calm), 5 (Very calm).

   Time frame: 30 days

Baseline characteristics

Study documents

• Protocol and statistical analysis plan · Dec 5, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Patients will be asked informed consent with the possibility to share the data

Time frame: Data will be made available from 1 year after the trial findings are published. This is available for up to 5 years after study completion.

Access criteria: We will make provision for and consider data sharing requests from bona fide researchers who must abide by the following principles: data will be collected with an high level of quality assurance, data will be held securely with appropriate documentation, data will not be put into the public domain or otherwise shared without explicit ethical review or legal obligation, and they will aim to use any data generated to the maximum public good. These datasets are governed by data usage policies specified by the data controller (UCL). If a conflict exists that severely restricts the analyses that can be undertaken, we would endeavour to support outside researchers by hosting them as visiting workers in our team so that they can access the data. We are committed to complying with the Wellcome Trust Data Sharing Policy. Applications are subject to review by Prof Lovat and Rawen Kader and should be emailed to l.lovat@ucl.ac.uk