Clinical trial NCT05513261: Clinical Validation of PolyDeep: an Artificial Intelligence-based Computer-aided Polyp Detection (CADe) and Characterization (CADx) System. Polydeep Advance 3
Official title: PolyDeep Advance 3: Randomized Clinical Trial Comparing High Definition Colonoscopy With PolyDeep Assisted High Definition Colonoscopy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: Colorectal adenomas
Colorectal polyps
Serrated lesions
Polydeep
computer-aided System
Lead sponsor: Fundacin Biomedica Galicia Sur
Sponsor class: OTHER
Collaborators: name: Ministerio de Ciencia e Innovación, Spain
name: Ministry of Work and Welfare - Xunta de Galicia
name: Asociación Española de Gastroenterología
name: European Regional Development Fund
First posted: 2022-08-24
Enrollment: 857
Sex: ALL
Minimum age (years): 40
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients who fulfill criteria will be randomly allocated to high definition colonoscopy or Polydeep assisted high definition colonoscopy.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Adenoma Detection Rate (ADR)
timeFrame: 1.5 years
Secondary outcomes:
measure: Polyp detection rate
timeFrame: 1.5 years
measure: Serrated lesion detection rate
timeFrame: 1.5 years
measure: Advanced lesion detection rate
timeFrame: 1.5 years
measure: Withdrawal time:
timeFrame: 1.5 years
measure: Characterization of the detected lesions.
timeFrame: 1.5 years
Other outcomes:
Locations:
city: Vigo
country: Spain
facility: Hospital Álvaro Cunqueiro (Vigo)
state: Pontevedra
city: Ourense
country: Spain
facility: Complexo Hospitalario Universitario de Ourense
city: Pontevedra
country: Spain
facility: Hospital de Montecelo
Study officials:
References:
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