Computer Aided Diagnosis of Colorectal Polyps

NCT04510545 | Completed

• 1 other identifier: 260047
• Study Type: observational
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess whether computer aided technology (CAD) can help in the diagnosis of polyps found the bowel compared with visual inspection alone and therefore whether it is beneficial in helping clinicians to decide whether to remove a polyp or not. Presently, most endoscopists remove all polyps found and send them to the laboratory for testing. The number of colonoscopies is increasing, meaning that more polyps are detected and removed. This comes at a significant cost to the health service and increases the time taken to complete a colonoscopy.

Conditions

Colonic Polyp; Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• True positive adenoma detection rate

  True positive adenoma detection rate with visual inspection versus true positive adenoma detection rate with visual inspection plus CAD

  6 months

Secondary Outcomes (7)

• True negative adenoma detection rate

  6 months

• To estimate the sensitivity, specificity, of visual inspection and the use of the EndoBRAIN CAD technology

  6 months

• To estimate the positive predictive value [PPV], and NPV of the combination of visual inspection and the use of the EndoBRAIN CAD technology

  6 months

• To estimate the percentage of diminutive colorectal polyps from which endocytoscopic images can be successfully captured (acquisition rate).

  6 months

• To estimate the rate of high-confidence diagnosis with EndoBRAIN as compared to visual polyp inspection alone.

  6 months

Study Arms (1)

Treatment Group

All patients will undergo CAD of any diminutive polyps found in the rectosigmoid on colonoscopy

Diagnostic Test: Endobrain, Computer Aided Diagnosis (CAD)

Interventions

Endobrain, Computer Aided Diagnosis (CAD) DIAGNOSTIC_TEST

Artificial intelligence

Treatment Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any patient 18 years or older scheduled for screening, surveillance, diagnostic, or therapeutic colonoscopy at King's College Hospital with diminutive rectosigmoid polyps.

You may qualify if:

• Individuals 18 years or older who are scheduled for screening, surveillance, diagnostic, or therapeutic colonoscopy at at King's College Hospital with diminutive rectosigmoid polyps.

You may not qualify if:

• Diminutive polyps with known histology
• Inflammatory bowel disease
• Polyposis syndrome (e.g., familial adenomatous polyposis, serrated polyposis)
• History of chemotherapy or radiation therapy for colorectal lesions
• Inability to undergo polypectomy (e.g. intake of anticoagulants, comorbidities, or patient refusal)
• Pregnancy

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead

Study Sites (1)

King's College Hospital

London, SE5 9RS, United Kingdom

Location

MeSH Terms

Conditions

Colonic Polyps; Colorectal Neoplasms

Interventions

Diagnosis, Computer-Assisted

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Diagnosis

Study Design

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

Study Record Dates

• First Submitted: September 24, 2019
• First Posted: August 12, 2020
• Study Start: June 1, 2020
• Primary Completion: May 5, 2021
• Study Completion: May 5, 2021
• Last Updated: January 31, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)