Polyp REcognition Assisted by a Device Interactive Characterization Tool - The PREDICT Study

NCT04589078 | Completed FDA Device

• 1 other identifier: CB-17-08/05
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Diminutive colorectal polyps (≤ 5 mm) represent most of the polyps detected during colonoscopy, especially in the rectum-sigmoid tract. The characterization of these polyps by virtual chromoendoscopy is recognized as a key element for innovative imaging techniques. As a matter of facts diminutive colorectal polyps are very frequent and, if located in the rectosigmoid colon, they present a very low malignant risk (0.3% of evolution towards advanced adenoma and up to 0.08% of evolution towards invasive carcinoma). The real-time characterization would allow to identify the lowest risk polyps (hyperplastic subtype), to leave them in situ or, if resected, not to send them for histological examination, allowing a huge saving in healthcare associated costs. Recently, the American Society for Gastrointestinal Endoscopy (ASGE) Technology Committee established the Preservation and Incorporation of Valuable endoscopic Innovations (PIVI) document, specific for real-time histological assessment for tiny colorectal polyps, to establish reference quality thresholds. Two performance standards have been developed to guide the use of advanced imaging:

1. 1.for diminutive polyps to be resected and discarded without pathologic assessment, endoscopic technology (when used with high confidence) used to determine histology of polyps ≤ 5mm in size, when combined with the histopathology assessment of polyps \> 5 mm in size, should provide a ≥ 90% agreement in assignment of post-polypectomy surveillance intervals when compared to decisions based on pathology assessment of all identified polyps;
2. 2.in order for a technology to be used to guide the decision to leave suspected rectosigmoid hyperplastic polyps ≤ 5 mm in size in place (without resection), the technology should provide ≥ 90% negative predictive value (when used with high confidence) for adenomatous histology.

Conditions

Artificial Intelligence

Outcome Measures

Primary Outcomes (1)

• Negative Predictive Value of histology prediction on diminutive (≤5 mm) rectosigmoid polyps

  1 day

Secondary Outcomes (1)

• Agreement in assignment of post-polypectomy surveillance intervals

  1 day

Other Outcomes (1)

• Sensitivity, Specificity, Accuracy, PPV and NPV of GI Genius CADx histology prediction and endoscopist assessment on all the identified lesions

  1 day

Study Arms (1)

Interficial Intelligence

Each patient will undergo standard white-light colonoscopy with the support of the latest version of the CE marked GI Genius CADe available.

Device: GI Genius CADe system

Interventions

GI Genius CADe system DEVICE

Each patient will undergo standard white-light colonoscopy with the support of the latest version of the CE marked GI Genius CADe available.

Interficial Intelligence

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged 40-80 undergoing colonoscopy

You may qualify if:

• Patients aged 40-80 undergoing screening colonoscopy for CRC
• Ability to provide written, informed consent (approved by EC) and understand the responsibilities of trial participation.

You may not qualify if:

• subjects positive to Fecal Immunochemical Test or Fecal Occult Blood Test;
• subjects undergoing CRC surveillance colonoscopy
• subject at high risk for CRC
• subjects with a personal history of CRC, IBD or hereditary polyposic or non-polyposic syndromes;
• patients with previous resection of the sigmoid rectum;
• patients on anticoagulant therapy, which precludes resection / removal operations due to histopathological findings;
• patients who perform an emergency colonoscopy.

Sponsors & Collaborators

• Cosmo Artificial Intelligence-AI Ltd: lead

Study Sites (1)

Endoscopy Unit, Humanitas Research Hospital

Rozzano, Milano, 20089, Italy

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2020
• First Posted: October 19, 2020
• Study Start: September 8, 2020
• Primary Completion: December 22, 2020
• Study Completion: December 22, 2020
• Last Updated: May 12, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)