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

Primary Purpose

Lynch Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Gi Genius, Medtronic
White light standart colonoscopy
Sponsored by
Hospital Clinic of Barcelona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lynch Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • María Pellisé. MD. PhD.Recruiting
  • Oswaldo ortizRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

CAD arm

WLE arm

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Withdrawal time
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
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
proportion of individuals undergoing a complete colonoscopy who had at least one adenoma detected between two arms.
Polyp detection rate
proportion of individuals undergoing a complete colonoscopy who had at least one polyp detected between two arms.
False positives in CAD arm
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
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
Questionary addresing the easiness and satisfaction of the procedure, detection of lesions and performance of artificial intelligence will be filled in by each endoscopist

Full Information

First Posted
May 21, 2021
Last Updated
March 16, 2022
Sponsor
Hospital Clinic of Barcelona
Collaborators
European Society of Gastrointestinal Endoscopy
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1. Study Identification

Unique Protocol Identification Number
NCT04909671
Brief Title
Evaluation of ArTificial Intelligence System (Gi-Genius) for adenoMa dEtection in Lynch Syndrome.
Acronym
Timely
Official Title
Evaluation of ArTificial Intelligence System (Gi-Genius) for adenoMa dEtection in Lynch Syndrome. A Randomized, Parallel, Multicenter, Controlled Trial. TIMELY Study.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 13, 2021 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Clinic of Barcelona
Collaborators
European Society of Gastrointestinal Endoscopy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lynch Syndrome

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
404 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CAD arm
Arm Type
Active Comparator
Arm Description
Patients allocated to CAD arm will receive during colonoscopy withdrawal high definition white light endoscopy aided with artificial intelligence device (Gi Genius, Medtronic)
Arm Title
WLE arm
Arm Type
Placebo Comparator
Arm Description
Patients allocated to WLE arm will receive during colonoscopy withdrawal high definition white light endoscopy as standart of care.
Intervention Type
Device
Intervention Name(s)
Gi Genius, Medtronic
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
White light standart colonoscopy
Intervention Description
High definition white light endoscopy will be used during the scope withdrawal
Primary Outcome Measure Information:
Title
Mean number of adenomas per colonoscopy
Description
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
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Withdrawal time
Description
time spent on inspection, from the cecum to endoscope extraction through the anus, excluding the time needed for therapeutic measures (including polypectomy).
Time Frame
18 months
Title
Mean number of polyps per colonoscopy
Description
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
Time Frame
18 months
Title
Adenoma detection rate
Description
proportion of individuals undergoing a complete colonoscopy who had at least one adenoma detected between two arms.
Time Frame
18 months
Title
Polyp detection rate
Description
proportion of individuals undergoing a complete colonoscopy who had at least one polyp detected between two arms.
Time Frame
18 months
Title
False positives in CAD arm
Description
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.
Time Frame
18 months
Title
Mean number of non-clinically significant removed lesions
Description
Lesions removed and with a histology of normal or inflammatory mucosa or removed diminutive recto-sigmoid polyps with a histology of hyperplastic
Time Frame
18 months
Title
Subjective endoscopist measures
Description
Questionary addresing the easiness and satisfaction of the procedure, detection of lesions and performance of artificial intelligence will be filled in by each endoscopist
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Pellise, Phd
Phone
+34 932275400
Ext
2675
Email
mpellise@clinic.cat
Facility Information:
Facility Name
María Pellisé. MD. PhD.
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
María Pellisé, MD. PhD.
Phone
+34 932275400
Ext
2675
Email
mpellise@clinic.cat
Facility Name
Oswaldo ortiz
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oswaldo ortiz
Phone
+34691371417
Email
oaortiz@clinic.cat

12. IPD Sharing Statement

Plan to Share IPD
No
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Evaluation of ArTificial Intelligence System (Gi-Genius) for adenoMa dEtection in Lynch Syndrome.

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