Computer Aided Detection, Tandem Colonoscopy Study

Colonic Diseases Clinical Trial

Official title:

Computer Aided Detection, Tandem Colonoscopy Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04074577
• Other study ID #: 19-00801
• Status: Completed
• Phase: N/A
• Start date: September 17, 2020
• Est. completion date: October 14, 2020

Study information

• Verified date: June 2021
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: October 14, 2020
• Est. primary completion date: October 14, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Colonic Diseases

Intervention

Diagnostic Test:
• Standard technique First
colonoscopy without automated polyp detection software
• combination technique First
automated polyp detection software

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of adenomas detected in combination technique compared to adenomas detected in standard technique Measured by Adenoma Miss Rate (AMR)	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.	1 Year