Neoplasms

All Conditions

Digestive System Diseases

Symptoms and General Pathology

Adenoma

Colorectal Neoplasms

Gastrointestinal Neoplasms

Intestinal Neoplasms

Polyps

Digestive System Neoplasms

Patients will be examined with Conventional Colonoscopy (CC)

Patients will be examined with Magentiq Eye Assisted Colonoscopy (MEAC)

Patients in Group A (CC) will undergo Screening or Surveillance Conventual Colonoscopy, Patients in Group B (MEAC) will undergo Screening or Surveillance Colonoscopy with ME-ADPS Device

Screening or Surveillance Conventionall colonoscopy

Peter Siersema, MD, Ph.D.

ME-APDS is a device (software-based with hardware) developed by Magentiq Eye LTD and intended to support the decision of the endoscopist on polyps which appear in the colonoscopy video during the colonoscopy procedure.

This randomized two arm colonoscopy trial will mainly compare APC and APE between Magentiq Eye Assisted Colonoscopy (MEAC) and Conventional Colonoscopy (CC) in patients referred for either screening or surveillance colonoscopies.

The primary objective of the present study is to compare the number of Adenomas Per Colonoscopy (APC) and the Adenomas Per Extraction (APE) between the Magentiq Eye-Assisted Colonoscopy (MEAC) and Conventional Colonoscopy (CC). These are also the co-primary endpoints.

The secondary endpoints are Adenoma Miss Rate (AMR, tested on part of the total study population) and Adenoma Detection Rate (ADR).

This study mainly hypothesizes that more adenomas will be detected in MEAC compared to CC (higher APC in MEAC compared to CC), and that the reduction of APE in MEAC compared to CC (if there will be a reduction) will be limited.

The study also assumes that AMR will be reduced in MEAC compared to CC and that ADR will increase to some level in MEAC compared to CC.

The study will include 952 subjects . Eligible patients will be randomized in a 1:1 ratio into two groups, group A and B. In group A, patients will be examined with CC. Patients in group B will be examined using MEAC. Immediately after the randomization, a sub-randomization will be performed on whether an immediate second examination (for AMR calculation) will be conducted or not (136 patients will undergo second examination).

The colonoscopy will be performed in accordance with the standard of care of each medical center in either MEAC or CC.

After the colonoscopy procedure patients will be observed at the endoscopy unit until the discharge criteria are met as per the standard clinical protocol of the medical center. After here, they will be discharged by the treating physician.

Study follow-up period will be up to 30-days post-colonoscopy to register (serious) adverse events and it will be in accordance with the standard of care of medical center.

A Study to Evaluate the Safety and Efficacy of the Use of ME-APDS During Colonoscopy

A Randomized Two Arm Multi-Center Study to Evaluate the Safety and Efficacy of the Use of Magentiq Eye's Automatic Polyp Detection System (ME-APDS) During Colonoscopy

Compare the APC of the Magentiq Eye Assisted Colonoscopy (MEAC) with the Conventional Colonoscopy (CC)

Magentiq Eye LTD

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

The Medtronic-GI genius (CADe) system can be used to detect polyps of all sizes. Use of CADe is left to the discretion of the treating physician performing the colonoscopy. If used CADe will provide real-time feedback throughout each colonoscopy procedure and will alert the endoscopists of the presence of a polyp in the endoscopy field by displaying a bounding box on the same screen.

In the control group (standard colonoscopy), the participating endoscopists will detect and classify colorectal lesions without using any AI modules.

Medtronic-GI genius: AI will provide real-time feedback throughout each colonoscopy procedure and alert endoscopists to the presence of a polyp in the endoscopy field by displaying a bounding box on the same screen.

Medtronic-GI genius (CADe system for detecting colorectal polyps)

Julie Fleury

Daniel von Renteln, MD

Simon Bouchard, MD

Erik Deslandres, MD

Mickael Bouin, MD

Daniel von Renteln

This is a pragmatic, double-blind, randomized, controlled trial, to evaluate the effect of implementing a CADs system within the routine clinical practice of Canadian healthcare institutions.

The main hypothesis of this study is that the ADR in the operating room equipped with the GI genius CADe system will be significantly higher than the ADR in the ordinary operating room.

This trial will be conducted in four centers across Canada. All patients who meet the in/exclusion criteria can be enrolled. The patient's personal medical history will be reviewed to verify patient inclusion and exclusion criteria (age, history of CRC or adenoma, comorbid conditions, anticoagulation, etc.).

Eligible patients will be randomized (1:1) stratified per center in two arms:

1. Intervention arm: patients will be assigned to undergo colonoscopy in a room equipped with the GI genius CAD system.
2. Control arm: patients will undergo colonoscopy in a room not equipped with the GI genius CADe system.

The endoscopists performing the colonoscopies will not be involved in the development and implementation of CADe. Additionally, they won't be informed of the ongoing trial and will have the option of not using the CADe when available in the room. This design aims to mitigate operator biases that may be partly responsible for the observed difference between the CADe performance in randomized controlled trials and the CADe performance in implementation studies.

Data will be collected on case report forms (CRF), after the procedure, from the clinical files and the endoscopy reports. The data will then be deidentified and transferred to an electronic RedCap database in each institution. A research assistant will collect all information and annotations recorded on the patient's medical file during the procedure.

In the treatment group (operating room equipped with the CADe), the Medtronic-GI genius system can be used for real-time support by the endoscopists to detect polyps of all sizes. Use of CADe is left to the discretion of the treating physician performing the colonoscopy. If used CADe will provide real-time feedback throughout each colonoscopy procedure and will alert the endoscopists of the presence of a polyp in the endoscopy field by displaying a bounding box on the same screen.

In the control group (colonoscopy performed in room without CADe system), the participating endoscopists will detect as per standard of care.

All colonoscopies (in the intervention and control groups) including polypectomy procedures will be performed at the discretion of the treating physician and per standard of care.

All polyps will be resected and sent to the pathology labs of the participating institutions to be evaluated for histology by board-certified pathologists. The histopathology outcomes will be collected and stored in the CRF forms to be used as a reference later.

pragmatic double-blinded, randomized, multi-endoscopist, multicenter

Allocation will be concealed; the the patients and the participating endoscopists will not be informed of the treatment group.

Artificial Intelligence (AI) Assisted Real-time Adenoma Detection During Colonoscopies

To assess whether the GI genius platform can significantly increase the ADR during live colonoscopies, compared to standard colonoscopy among high-risk patients.The ADR is defined as the proportion of patients undergoing GI genius-assisted/standard colonoscopy in whom superior or equal to 1 histopathologically proven adenoma or carcinoma is identified. We will use the histopathology outcomes of the resected polyps as the ground truth to calculate the ADR.

The probability of an increase in the ADR among the trainees and expert endoscopists when using GI genius AI-assisted colonoscopy compared to standard colonoscopies.

Proximal ADR is defined as the prevalence of patients with at least 1 adenoma detected proximal to the splenic flexure

Sessile serrated lesions (SSL) detection rate as the proportion of patients colonoscopy in whom superior or equal to 1 sessile serrated lesion (SSL) is identified

Mean number of adenomas per colonoscopy (APC) defined as the total number of adenomas divided by the number of colonoscopies performed

Adenomas per positive index colonoscopy (APPC) defined as the total number of adenomas divided by the total of colonoscopies where at least 1 adenoma is detected

Sessile serrated lesion per Colonoscopy (SSLPC), defined as the total number of histologically confirmed sessile serrated lesions resected divided by the total number of colonoscopies

Advanced lesion detection rate (ALDR), defined as the proportion of colonoscopies for which the number of histopathologically proven adenoma \>10mm was at least 1.

To evaluate the agreement between the surveillance intervals based on the optical diagnosis of polyps with the GI genius and the pathology-based recommendation according to the current guidelines.

Proportion neoplastic and non-neoplastic polyps (i.e., SSLs, hyperplastic polyps, and high-grade dysplasia and carcinomas (overall and according to size, location, and morphology)

CADe utilization rate (when available in the room). Since we can't directly assess the CADe utilization rate without revealing the ongoing trial to the endoscopists, we will rely on two voluntary self-reported measures and a partial objective measure.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study to Evaluate the Safety and Efficacy of the Use of ME-APDS During Colonoscopy	NCT04640792	Screening Colon... Surveillance Co...	Screening or Su...	18 Years - 90 Years	Magentiq Eye LTD
Artificial Intelligence (AI) Assisted Real-time Adenoma Detection During Colonoscopies	NCT05244278	Artificial Inte...	Medtronic-GI ge...	45 Years - 89 Years	Centre hospitalier de l'Université de Montréal (CHUM)

Spots Global Cancer Trial Database for adenoma per colonoscopy