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

Hospital Clinic of Barcelona

Status: Unknown

Conditions: Lynch Syndrome

Treatments: Other: White light standart colonoscopy; Device: Gi Genius, Medtronic

Study type: Interventional

Funder types: Other

Identifiers

NCT04909671

Timely

Details and patient eligibility

About

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.

Full 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).

Enrollment: 404 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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404 participants in 2 patient groups, including a placebo group

CAD arm

Active Comparator group

Description:

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

Treatment:

Device: Gi Genius, Medtronic

WLE arm

Placebo Comparator group

Description:

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

Treatment:

Other: White light standart colonoscopy