Clinical Validation of Polydeep: an Artificial Intelligence-based Computer-aided Polyp Detection (CADe) and Characterization (CADx) System. Polydeep Advance 2.

Sponsor

Fundacin Biomedica Galicia Sur (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05512793

Collaborator

(none)

260

Enrollment

Locations

Arms

Anticipated Duration (Months)

86.7

Patients Per Site

7.2

Patients Per Site Per Month

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 2 is a multicentric randomized clinical trial with a tandem colonoscopy design. The hypothesis of this study is that Polydeep assisted colonoscopy will reduce the number of missed adenomas in the first withdrawal.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer	Diagnostic Test: Standard technique First colonoscopy without Polydeep Diagnostic Test: Combination technique First colonoscopy with Polydeep	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 This clinical trial is part of the clinical validation of Polydeep. We will perform a randomized clinical trial with a tandem colonoscopy design with adenoma miss rate as the main objective.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

260 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Patients who fulfill criteria will be randomly allocated to perform the first withdrawal with the standard technique versus Polydeep assisted colonoscopy. All colorectal detected polyps will be resected. After a second cecal intubation, second withdrawal will be performed with the opposite techniquePatients who fulfill criteria will be randomly allocated to perform the first withdrawal with the standard technique versus Polydeep assisted colonoscopy. All colorectal detected polyps will be resected. After a second cecal intubation, second withdrawal will be performed with the opposite technique

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Polydeep Advance 2: Clinical Validation of Polydeep. Randomized Clinical Trial With a Tandem Colonoscopy Design.

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Jan 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard Technique followed by Combination Back-to-back tandem colonoscopies by the same endoscopist. The first colonoscopy will be performed without Polydeep (standard technique) followed immediately by another colonoscopy with Polydeep (combination technique).	Diagnostic Test: Standard technique First colonoscopy without Polydeep Standard technique First colonoscopy without Polydeep
Active Comparator: Combination followed by Standard Technique Back-to-back tandem colonoscopies by the same endoscopist. In this arm, the first colonoscopy with be performed with Polydeep (combination technique) followed immediately by another colonoscopy without Polydeep (standard technique)	Diagnostic Test: Combination technique First colonoscopy with Polydeep Combination technique First colonoscopy with Polydeep

Arm

Intervention/Treatment

Active Comparator: Standard Technique followed by Combination

Back-to-back tandem colonoscopies by the same endoscopist. The first colonoscopy will be performed without Polydeep (standard technique) followed immediately by another colonoscopy with Polydeep (combination technique).

Diagnostic Test: Standard technique First colonoscopy without Polydeep

Standard technique First colonoscopy without Polydeep

Active Comparator: Combination followed by Standard Technique

Back-to-back tandem colonoscopies by the same endoscopist. In this arm, the first colonoscopy with be performed with Polydeep (combination technique) followed immediately by another colonoscopy without Polydeep (standard technique)

Diagnostic Test: Combination technique First colonoscopy with Polydeep

Combination technique First colonoscopy with Polydeep

Outcome Measures

Primary Outcome Measures

Adenoma miss rate (AMR) [1 Year]
AMR will be calculated as the number of adenomas detected on the withdrawal or portion in either group divided by the total number of adenomas detected during both withdrawals

Secondary Outcome Measures

Polyp miss rate [1 Year]
It will be calculated as the number of polyps detected on the withdrawal or portion in either group divided by the total number of polyps detected during both withdrawals
Serrated lesions miss rate [1 Year]
It will be calculated as the number of serrated lesions detected on the withdrawal or portion in either group divided by the total number of serrated lesions detected during both withdrawals
Characterization of the detected lesions. [1 Year]
We will evaluate the optical diagnosis accuracy of Polydeep for the final histological diagnosis (sensitivity, specificity, positive and negative predictive values).
Withdrawal time. (First/second colonoscopy) [1 Year]
Withdrawal time between the two arms will be calculated and compared.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 79 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

First diagnostic colonoscopy performed after a positive fecal immunochemical test performed within the CRC screeening program.
Surveillance after colorectal adenomas resection.
Authorization after reading the information sheet and singing the informed consent.

Exclusion Criteria:

Incomplete colonoscopy without cecal intubation.
Colonoscopies with insufficient intestinal cleansing (Boston Bowel Preparation Scale <6 or <2 in any of the evaluated segments).
Detected lesions without histological diagnosis.
Previous CRC.
Previous colonic resection.
CRC associated hereditary syndrome.
Serrated polyposis syndrome.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Complexo Hospitalario Universitario de Ourense	Ourense	Spain	32002
2	Complexo Hospitalario Universitario de Pontevedra	Pontevedra	Spain	36071
3	Hospital Álvaro Cunqueiro	Vigo	Spain	36211

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:

NCT05512793

Other Study ID Numbers:

Polydeep Advance 2.0

First Posted:

Aug 23, 2022

Last Update Posted:

Aug 23, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Fundacin Biomedica Galicia Sur

Colorectal Adenoma

Colorectal Serrated Lesions

Colorectal Polyps

Computer-Aided polyp Detection (CAD)

Additional relevant MeSH terms:

Colorectal Neoplasms

Study Results

No Results Posted as of Aug 23, 2022