Computer Aided Detection, Tandem Colonoscopy Study

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04074577

Enrollment

Registered

2019-08-30

Start date

2020-09-17

Completion date

2020-10-14

Last updated

2021-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colonic Diseases

Brief summary

The purpose of this project is to examine the role of machine learning and computer aided diagnostics in automatic polyp detection and to determine in real-time how a computer-aided detection (CADe) algorithm will perform when compared to standard screening or surveillance colonoscopy alone. Design will be a multi-center, prospective, unblinded randomized tandem colonoscopy study. 196 patients referred for either screening or surveillance colonoscopy will be included.

Interventions

DIAGNOSTIC_TESTStandard technique First

colonoscopy without automated polyp detection software

DIAGNOSTIC_TESTcombination technique First

automated polyp detection software

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

22 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Patients presenting to the endoscopy unit for a screening colonoscopy or a surveillance colonoscopy * Willingness to undergo tandem colonscopies with and without the use of computer-aided software while undergoing conventional colonoscopy with sedation * Ability to provide written, informed consent (approved by IRB) and understand the responsibilities of trial participation

Exclusion criteria

* People with diminished cognitive capacity * Patients undergoing diagnostic colonoscopy (e.g. as an evaluation for active GI bleed) * Patients with incomplete colonoscopies (those where endoscopists did not successfully intubate the cecum due to technical difficulties or poor bowel preparation) * Patients that have standard contraindications to colonoscopy in general (e.g. documented acute diverticulitis, fulminant colitis and known or suspected perforation). * Patients with inflammatory bowel disease * Patients referred for endoscopic mucosal resection (EMR)

Design outcomes

Primary

Measure	Time frame	Description
Number of adenomas detected in combination technique compared to adenomas detected in standard technique Measured by Adenoma Miss Rate (AMR)	1 Year	AMR will be calculated as the number of adenomas detected on the second pass or portion in either group divided by the total number of adenomas detected during both passes.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026