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Development of a Computer-aided Polypectomy Decision Support

Primary Purpose

Adenomatous Polyps

Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Computer-aided polypectomy decision support by Artificial Intelligence
Sponsored by
Centre hospitalier de l'Université de Montréal (CHUM)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Adenomatous Polyps focused on measuring Polyps detection, Artificial Intelligence, Adenoma detection, Polyps classification, Computer decision support

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Signed informed consent
  • Age 45-80 years
  • Indication to undergo a lower GI endoscopy.

Exclusion Criteria:

  • Known inflammatory bowel disease
  • Active colitis
  • Coagulopathy
  • Familial polyposis syndrome;
  • Poor general health, defined as an American Society of Anesthesiologists (ASA) physical status class >3
  • Emergency colonoscopies

Sites / Locations

  • Centre Hospitalier Universitaire de Montréal

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Artificial intelligence for real-time Computer decision support of resection of colorectal polyps

Arm Description

A standard colonoscopy will be performed according to the standard of routine care. All optically diagnosed polyps will be removed and sent to the CHUM pathology laboratory for histopathological evaluation according to institutional standards. The AI system will capture video of the procedure in real time, and provide additional information about polypectomy procedures.

Outcomes

Primary Outcome Measures

Accuracy of the CADp system
accuracy with which the CADp system predicts completeness of polypectomy in the test set with the reference standard for completeness being determined by the histology of post-polypectomy margin biopsies; if free from any polyp tissue (adenomatous, serrated or hyperplastic), the resection will be considered complete. If remnant polyp tissue is detected in any one or more of the margin biopsies the resection is deemed incomplete
Completeness of polypectomy
We will evaluate the agreement between the different subjective and objective ways of assessing the completeness of the polypectomy : evaluation of margins (presence or not, measurement of margins) by endoscopists self-assessment, and by expert consensus.
Training CADp
Evaluation of the concordance of data on polyp size, extension of margins around the polyp, quality of resection between clinical data (endoscopists' self-assessment and experts' assessments) and CADp prediction.
Validity of the choice of primary outcome
Based on the results and comparison of the different assessment methods, we will perform sensitivity analyses to assess the validity and robustness of the choice of primary outcome.

Secondary Outcome Measures

Full Information

First Posted
February 16, 2021
Last Updated
December 9, 2022
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
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1. Study Identification

Unique Protocol Identification Number
NCT04811937
Brief Title
Development of a Computer-aided Polypectomy Decision Support
Official Title
Development of a Computer-aided Polypectomy Decision Support
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Withdrawn
Why Stopped
The study was abandoned due to the Covid pandemic which prevented recruitment.
Study Start Date
December 2021 (Anticipated)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
April 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)

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
Quality components of colonoscopy include the detection and complete removal of colorectal polyps, which are precursors to CRC. However, endoscopic ablation may be incomplete, posing a risk for the development of "interval cancers". The investigators propose to develop a solution based on artificial intelligence (AI) (CADp computer-aided decision support polypectomy) to solve this problem.This research project aims to develop CADp, a computer decision support solution (CDS) for the ablation of colorectal polyps from 1 to 20 mm.
Detailed Description
This research project aims to develop CADp, a computer-based decision support (CDS) solution for the removal of colorectal polyps ranging from 1-20 mm. The investigators will use a video and image dataset of polypectomy procedures to train the CADp model; thus, it can provide real-time overlaid video feedback for polypectomy procedures based on five specific metrics: 1) estimation of polyp size; 2) prediction of morphology and histology; 3) suggestion of an appropriate resection accessory and technical approach based on the characteristics, size, and histology of the polyp according to current guidelines; 4) image overlay, based on semantic image segmentation technology, showing the extent of the lesion and suggestion of an appropriate resection margin contour around the polyp to ensure its complete removal; 5) post-resection analysis to identify any remnant polyp tissue or insufficient resection margin that may increase this risk. The investigators will collect a set of images and video data from live polypectomy procedures to leverage recent advances in AI technology to train deep learning models. This dataset will be obtained prospectively from a cohort of adults (ages 45-80) undergoing screening, diagnostic, or surveillance colonoscopies. To train the CADp solution, the investigators will obtain the corresponding completeness of resection status using the yield of post-resection margin biopsies. The dataset will be divided into two groups, the training, and the CADp test, respectively.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenomatous Polyps
Keywords
Polyps detection, Artificial Intelligence, Adenoma detection, Polyps classification, Computer decision support

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
prospective, multi-endoscopist, single center, clinical study at tertiary referral center (CHUM)
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Artificial intelligence for real-time Computer decision support of resection of colorectal polyps
Arm Type
Experimental
Arm Description
A standard colonoscopy will be performed according to the standard of routine care. All optically diagnosed polyps will be removed and sent to the CHUM pathology laboratory for histopathological evaluation according to institutional standards. The AI system will capture video of the procedure in real time, and provide additional information about polypectomy procedures.
Intervention Type
Diagnostic Test
Intervention Name(s)
Computer-aided polypectomy decision support by Artificial Intelligence
Intervention Description
The AI system will capture the live video of the procedure and the AI feedbackwill be shown on a second screen installed next to the regular endoscopy screen. Screen A will show the regular endoscopy image and screen B will show the regular endoscopy image together with the areas that might harbor a polyp and the information to help the polypectomy.
Primary Outcome Measure Information:
Title
Accuracy of the CADp system
Description
accuracy with which the CADp system predicts completeness of polypectomy in the test set with the reference standard for completeness being determined by the histology of post-polypectomy margin biopsies; if free from any polyp tissue (adenomatous, serrated or hyperplastic), the resection will be considered complete. If remnant polyp tissue is detected in any one or more of the margin biopsies the resection is deemed incomplete
Time Frame
3 weeks
Title
Completeness of polypectomy
Description
We will evaluate the agreement between the different subjective and objective ways of assessing the completeness of the polypectomy : evaluation of margins (presence or not, measurement of margins) by endoscopists self-assessment, and by expert consensus.
Time Frame
1 month
Title
Training CADp
Description
Evaluation of the concordance of data on polyp size, extension of margins around the polyp, quality of resection between clinical data (endoscopists' self-assessment and experts' assessments) and CADp prediction.
Time Frame
1 month
Title
Validity of the choice of primary outcome
Description
Based on the results and comparison of the different assessment methods, we will perform sensitivity analyses to assess the validity and robustness of the choice of primary outcome.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed informed consent Age 45-80 years Indication to undergo a lower GI endoscopy. Exclusion Criteria: Known inflammatory bowel disease Active colitis Coagulopathy Familial polyposis syndrome; Poor general health, defined as an American Society of Anesthesiologists (ASA) physical status class >3 Emergency colonoscopies
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel von Renteln
Organizational Affiliation
Centre hospitalier de l'Université de Montréal (CHUM)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire de Montréal
City
Montréal
State/Province
Quebec
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Development of a Computer-aided Polypectomy Decision Support

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