Timely: Evaluation of ArTificial Intelligence System (Gi-Genius) for adenoMa dEtection in Lynch Syndrome.

Sponsor

Hospital Clinic of Barcelona (Other)

Overall Status

Recruiting

CT.gov ID

NCT04909671

Collaborator

European Society of Gastrointestinal Endoscopy (Other)

404

Enrollment

Locations

Arms

26.6

Anticipated Duration (Months)

202

Patients Per Site

7.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to assess if artificial intelligence aid colonoscopy colonoscopy is superior to conventional colonoscopy for the detection of adenomas during surveillance colonoscopy in patients with Lynch syndrome.

Condition or Disease	Intervention/Treatment	Phase
Lynch Syndrome	Device: Gi Genius, Medtronic Other: White light standart colonoscopy	N/A

Detailed Description

To compare the performance of white-light colonoscopy (HD-WLE) versus white-light + CAD (CAD) for detection of adenomas (1:1 ratio). The CAD system will include an artificial intelligence-based medical device (GI Genius, Medtronic) trained to process colonoscopy images and superimpose them, in real time, on the endoscopy display as a green box over suspected lesion. An adequate bowel preparation and minimum withdrawal time of 6 min will be required. Colonoscopies will be performed by experienced endoscopists and with high-definition scopes. Lesions will be collected, and histopathology findings used as the reference standard. The primary outcome of this trial will be the mean number of adenomas per colonoscopy (APC).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

404 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Diagnostic

Official Title:

Evaluation of ArTificial Intelligence System (Gi-Genius) for adenoMa dEtection in Lynch Syndrome. A Randomized, Parallel, Multicenter, Controlled Trial. TIMELY Study.

Actual Study Start Date :

Sep 13, 2021

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: CAD arm Patients allocated to CAD arm will receive during colonoscopy withdrawal high definition white light endoscopy aided with artificial intelligence device (Gi Genius, Medtronic)	Device: Gi Genius, Medtronic GI geniusTM (Medtronic) is an artificial intelligence device designed and validated on a dataset of white-light endoscopy videos from high-quality randomized controlled trials for the detection of colorectal lesions during colonoscopy. Based on a deep learning system using convolutional neural networks, GI genius works in real-time side-to-side with the gastroenterologist during colonoscopy highlighting the presence of precancerous lesions with a visual marker (green box) in real time and designed to be integrated with the majority of colonoscopies.
Placebo Comparator: WLE arm Patients allocated to WLE arm will receive during colonoscopy withdrawal high definition white light endoscopy as standart of care.	Other: White light standart colonoscopy High definition white light endoscopy will be used during the scope withdrawal

Arm

Intervention/Treatment

Active Comparator: CAD arm

Patients allocated to CAD arm will receive during colonoscopy withdrawal high definition white light endoscopy aided with artificial intelligence device (Gi Genius, Medtronic)

Device: Gi Genius, Medtronic

GI geniusTM (Medtronic) is an artificial intelligence device designed and validated on a dataset of white-light endoscopy videos from high-quality randomized controlled trials for the detection of colorectal lesions during colonoscopy. Based on a deep learning system using convolutional neural networks, GI genius works in real-time side-to-side with the gastroenterologist during colonoscopy highlighting the presence of precancerous lesions with a visual marker (green box) in real time and designed to be integrated with the majority of colonoscopies.

Placebo Comparator: WLE arm

Patients allocated to WLE arm will receive during colonoscopy withdrawal high definition white light endoscopy as standart of care.

Other: White light standart colonoscopy

High definition white light endoscopy will be used during the scope withdrawal

Outcome Measures

Primary Outcome Measures

Mean number of adenomas per colonoscopy [18 months]
Compare mean number of adenomas in both arms calculated by dividing the total number of adenomas detected by the total number of colonoscopies in each arm

Secondary Outcome Measures

Withdrawal time [18 months]
time spent on inspection, from the cecum to endoscope extraction through the anus, excluding the time needed for therapeutic measures (including polypectomy).
Mean number of polyps per colonoscopy [18 months]
Compare mean number of polyps in both arms calculated by dividing the total number of polyps (including serrated lesions and adenomas) detected by the total number of colonoscopies in each arm
Adenoma detection rate [18 months]
proportion of individuals undergoing a complete colonoscopy who had at least one adenoma detected between two arms.
Polyp detection rate [18 months]
proportion of individuals undergoing a complete colonoscopy who had at least one polyp detected between two arms.
False positives in CAD arm [18 months]
Combination of: Lesions detected by CAD (>2s green box) after an adequate inspection with a high confidence optical diagnosis negative for neoplasia made by the endoscopist. Lesions detected by CAD (>2s green box) after an adequate inspection resected by the endoscopist and with a clinically non-significant histology.
Mean number of non-clinically significant removed lesions [18 months]
Lesions removed and with a histology of normal or inflammatory mucosa or removed diminutive recto-sigmoid polyps with a histology of hyperplastic
Subjective endoscopist measures [18 months]
Questionary addresing the easiness and satisfaction of the procedure, detection of lesions and performance of artificial intelligence will be filled in by each endoscopist

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age ≥18 years with a proven pathogenic germline variant in one of the MMR genes (MLH1, MSH2, MSH6) or Epcam deletion who are under surveillance colonoscopy.

Exclusion Criteria:

Previous history of total colectomy,
Concomitant inflammatory bowel disease,
Inability or refuse to sign the informed consent,
Previous colonoscopy < 12 months.
Inadequate bowel preparation.
Incomplete procedure.
PMS2 mutation carriers

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	María Pellisé. MD. PhD.	Barcelona		Spain	08036
2	Oswaldo ortiz	Barcelona		Spain	08036

Sponsors and Collaborators

Hospital Clinic of Barcelona
European Society of Gastrointestinal Endoscopy

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

María Pellisé, Principal Investigator. Attending physician Gastroenterology department., Hospital Clinic of Barcelona

ClinicalTrials.gov Identifier:

NCT04909671

Other Study ID Numbers:

Timely

First Posted:

Jun 2, 2021

Last Update Posted:

Mar 17, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Adenoma

Colorectal Neoplasms, Hereditary Nonpolyposis

Syndrome

Study Results

No Results Posted as of Mar 17, 2022