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Clinical Trials/NCT05513261
NCT05513261CompletedNot Applicable

PolyDeep Advance 3: Randomized Clinical Trial Comparing High Definition Colonoscopy With PolyDeep Assisted High Definition Colonoscopy.

Fundacin Biomedica Galicia Sur3 sites in 1 country857 target enrollmentStarted: November 17, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
857
Locations
3
Primary Endpoint
Adenoma Detection Rate (ADR)

Study Overview

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).

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 (NBI International Colorectal Endoscopic) Classification has proposed use high definition endoscopes that have Narrow Band Imaging (NBI). 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, the CAD system 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. This CAD system 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. The investigators 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
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
40 Years to 79 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •First diagnostic colonoscopy performed after a positive fecal immunochemical 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

Arms & Interventions

Control arm: High definition colonoscopy

Other

Diagnostic test: Standard colonoscopy

Intervention: High definition colonoscopy (standard colonoscopy) in Adenoma Detection Rate (Diagnostic Test)

PolyDeep assisted high definition colonoscopy

Experimental

Diagnostic test: PolyDeep

Intervention: PolyDeep assisted high definition colonoscopy (CAD system) in Adenoma Detection Rate (Diagnostic Test)

Outcomes

Primary Outcomes

Adenoma Detection Rate (ADR)

Time Frame: 1.5 years

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

Secondary Outcomes

  • Serrated lesion detection rate(1.5 years)
  • Advanced lesion detection rate(1.5 years)
  • Withdrawal time:(1.5 years)
  • Characterization of the detected lesions.(1.5 years)
  • Polyp detection rate(1.5 years)

Investigators

Sponsor
Fundacin Biomedica Galicia Sur
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (3)

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