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

NCT04909671 | Unknown

• 1 other identifier: Timely
• Study Type: interventional
• Target: 404
• Locations: 1 country
• Sites: 2

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.

Conditions

Lynch Syndrome

Outcome Measures

Primary Outcomes (1)

• Mean number of adenomas per colonoscopy

  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

  18 months

Secondary Outcomes (7)

• Withdrawal time

  18 months

• Mean number of polyps per colonoscopy

  18 months

• Adenoma detection rate

  18 months

• Polyp detection rate

  18 months

• False positives in CAD arm

  18 months

Study Arms (2)

CAD arm

ACTIVE COMPARATOR

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

WLE arm

PLACEBO COMPARATOR

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

Other: White light standart colonoscopy

Interventions

Gi Genius, Medtronic DEVICE

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.

CAD arm

White light standart colonoscopy OTHER

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

WLE arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead
• European Society of Gastrointestinal Endoscopy: collaborator

Study Sites (2)

María Pellisé. MD. PhD.

Barcelona, 08036, Spain

RECRUITING

Oswaldo ortiz

Barcelona, 08036, Spain

RECRUITING

Related Publications (23)

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MeSH Terms

Conditions

Colorectal Neoplasms, Hereditary Nonpolyposis

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Neoplastic Syndromes, Hereditary; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; DNA Repair-Deficiency Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Maria Pellise, Phd

CONTACT

+34 932275400; mpellise@clinic.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator. Attending physician Gastroenterology department.

Study Record Dates

• First Submitted: May 21, 2021
• First Posted: June 2, 2021
• Study Start: September 13, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: March 17, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)