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OpenTrials
Completed

NCT Number: NCT04754347

Computer Aided Detection of Polyps in Colonoscopy

The aim of this study is to evaluate the clinical benefit and safety of using a computer aided detection device, Skout, for real-time polyp detection in colonoscopy procedures with the indication of screening or surveillance. One of the reasons for the development of interval colorectal cancers is polyps missed during colonoscopy. Our hypothesis is that with the aid of Skout, the adenomas detected per colonoscopy will increase, and it is plausible to believe that this increase in detection could reduce the incidence of interval cancers.

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Key information

Conditions

Colorectal Polyp Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Medical Center, Boston, Massachusetts, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Participants will be eligible for this study if they are:

  • Undergoing colonoscopy with screening, surveillance, or diagnostic indications.
  • Undergoing a procedure by a participating endoscopist.
  • Have given informed consent.

Exclusion criteria

Participants will not be eligible for this study if they:

  • Have a history of inflammatory bowel disease.
  • Have a history of familial adenomatous polyposis.
  • Are under the age of 40.
  • Have had a colonoscopy within the previous three (3) years.
  • Undergoing diagnostic colonoscopy with high-risk indications including iron deficiency anemia, abnormal CT imaging, unexplained weight loss, Lynch Syndrome, blood in stool or FIT positive test.
  • Entered with poor bowel preparation (inadequate for procedure as assessed by the Investigator).
  • Use anti-platelet agents or anticoagulants that preclude the removal of polyps during the procedure.

Treatment and study plan

Computer Aided Detection device

Device

The Computer Aided Detection device, Skout, is designed to help endoscopists detect potential colorectal polyps during colonoscopies. The system performs automated real-time analysis on endoscopic video data to identify potential polyps and produces an informational visual aid around the appropriate sections of the video frames on a display monitor.

Primary outcomes

  1. Adenomas per colonoscopy

    Time frame: At the end of the procedure, 1 day

    The total number of adenomas detected divided by the total number of colonoscopies.

  2. Positive predictive value

    Time frame: At the end of the procedure, 1 day

    The total number of adenomas and serrated lesions detected divided by the total number of extractions.

Secondary outcomes

  1. Adenoma detection rate

    Time frame: At the end of the procedure, 1 day

    The percentage of participants aged ≥50 years undergoing first-time screening colonoscopy who have one or more conventional adenomas detected.

  2. Sessile serrated lesions detected

    Time frame: At the end of the procedure, 1 day

    The total number of polyps with histology or serrated adenoma, traditional serrated adenoma or serrated lesion with cytological dysplasia, excluding hyperplastic polyps.

  3. Colorectal cancer surveillance interval

    Time frame: At the end of the procedure, 1 day

    The mean recommended timeframe for follow up colonoscopy.

Sponsors and collaborators

Lead sponsor

Iterative Scopes, Inc

Industry

Collaborators

  • University of Minnesota

Registry information

Official study title

Randomized, Controlled Trial of a Computer Aided Detection Device in Standard Colonoscopy

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 15, 2021
Registry last updated
Dec 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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