Clinical Validation of Polydeep: an Artificial Intelligence-based Computer-aided Polyp Detection (CADe) and Characterization (CADx) System. Polydeep Advance 3

Sponsor
Fundacin Biomedica Galicia Sur (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05513261
Collaborator
(none)
854
2
21.1

Study Details

Study Description

Brief Summary

This study is a clinical validation of Polydeep, a computer-aided polyp detection (CADe) and characterization (CADx) system. Polydeep Advance 3 is a multicentric randomized clinical trial comparing high definition colonoscopy with Polydeep assisted high definition colonoscopy. The hypothesis of the study is that the Polydeep assisted colonoscopy increases the Adenoma Detection Rate (ADR).

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: High definition colonoscopy (standard colonoscopy) in Adenoma Detection Rate
  • Diagnostic Test: Polydeep assisted high definition colonoscopy (CAD system) in Adenoma Detection Rate
N/A

Detailed Description

Colorectal cancer (CRC) is the most frequently cancer in western world. A fundamental tool for detection and prevention is the colonoscopy. The detection and endoscopic resection of colorectal polyps, the precursor lesion of CRC, can reduce CRC incidence and mortality. Adenoma Detection Rate is the most used endoscopic quality indicator. The improvement of this indicator is related to the reduction of postcolonoscopy CRC incidence and mortality.

Colorectal polyp diagnosis is based on endoscopic resection and histological analysis. An accurate optical diagnosis could avoid histological lesion of smaller lesions, reducing the costs associated with histological diagnosis. The NICE international classification has proposed the use of high definition endoscopes that have Narrow Band Imaging. However, NICE must be used by endoscopists who are sufficiently prepared and who have overcome the learning curve. Therefore, optical histology diagnosis with high accuracy independently of the center and the endoscopist is necessary.

Computer Aid Diagnosis (CAD) systems based on Artificial Intelligence are experiencing exponential development in the field of medical image analysis. The development of the CAD system is based on the creation of large databases of endoscopic images and/or videos, on the training, development and validation of diagnostic algorithms in such databases and, finally, on prospective clinical validation in patients undergoing colonoscopy. The goal of CAD systems in colonoscopy is double. First, it aims to increase the detection of polyps (CADe) in general, and of adenomas and serrated lesions in particular. The second objective is to characterize (CADx) the histology of detected lesion.

Polydeep CAD is a functional prototype. It is capable of detecting, locating and classifying colorectal polyps. In vivo validation data shows that Polydeep has high diagnostic accuracy for polyp identification and that this accuracy can be accommodated. The aim of Polydeep advance 3 is to compare Adenoma Detection Rate differences in a randomized clinical trial. We will compare the Adenoma Detection Rate between high definition colonoscopy and Polydeep assisted high definition colonoscopy, both in CRC screening and surveillance.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
854 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Patients who fulfill criteria will be randomly allocated to high definition colonoscopy or Polydeep assisted high definition colonoscopy.Patients who fulfill criteria will be randomly allocated to high definition colonoscopy or Polydeep assisted high definition colonoscopy.
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Polydeep Advance 3: Randomized Clinical Trial Comparing High Definition Colonoscopy With Polydeep Assisted High Definition Colonoscopy.
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Other: Control arm: High definition colonoscopy

Diagnostic test: Standard colonoscopy

Diagnostic Test: High definition colonoscopy (standard colonoscopy) in Adenoma Detection Rate
In the intervention of this arm we will apply the standard colonoscopy without computer-aided colonoscopy (polydeep)

Experimental: Polydeep assisted high definition colonoscopy

Diagnostic test: Polydeep

Diagnostic Test: Polydeep assisted high definition colonoscopy (CAD system) in Adenoma Detection Rate
In the intervention of this arm we will apply polydeep assisted high definition colonoscopy (CAD system).

Outcome Measures

Primary Outcome Measures

  1. Adenoma Detection Rate [1.5 years]

    Number of colonoscopies with adenomas/total number of colonoscopies. We will evaluate if there are differences between both arms.

Secondary Outcome Measures

  1. Polyp detection rate [1.5 years]

    Number of colonoscopies with polyps/total number of colonoscopies. We will evaluate if there are differences between both arms.

  2. Serrated lesion detection rate [1.5 years]

    Number of colonoscopies with serrated lesions/total number of colonoscopies. We will evaluate if there are differences between both arms.

  3. Advanced lesion detection rate [1.5 years]

    Number of colonoscopies with advanced lesions (adenomas≥10mm, villous histology or high grade dysplasia; serrated lesions with dysplasia or ≥10mm) /total number of colonoscopies. We will evaluate if there are differences between both arms.

  4. Withdrawal time: [1.5 years]

    Withdrawal time between the two arms will be calculated and compared.

  5. Characterization of the detected lesions. [1.5 years]

    We will evaluate the optical diagnosis accuracy of Polydeep for the final histological diagnosis (sensitivity, specificity, positive and negative predictive values).

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 79 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • First diagnostic colonoscopy performed after a positive fecal inmunochemichal test performed within the CRC screening program.

  • Surveillance after resection of colorectal adenomas

  • Acceptance after reading the information sheet and signing informed consent.

Exclusion Criteria:
  • Colonoscopies with insufficient intestinal cleansing (Boston Bowel Preparation Scale <6 or <2 in any of the evaluated segments).

  • Incomplete colonoscopy without cecal intubation.

  • Previous CRC

  • Previous colonic resection.

  • Hereditary CRC syndromes

  • Serrated polyposis syndrome

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Fundacin Biomedica Galicia Sur

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Fundacin Biomedica Galicia Sur
ClinicalTrials.gov Identifier:
NCT05513261
Other Study ID Numbers:
  • Polydeep Advance 3.0
First Posted:
Aug 24, 2022
Last Update Posted:
Aug 24, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Fundacin Biomedica Galicia Sur
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 24, 2022