Back to resultsComputer Aided Detection, Tandem Colonoscopy Study
Primary Purpose
Colonic Diseases
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard technique First
combination technique First
Sponsored by
About this trial
This is an interventional screening trial for Colonic Diseases
Eligibility Criteria
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)
Sites / Locations
- NYU Langone Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Standard Technique followed by Combination
Combination +followed by Standard Technique
Arm Description
Back-to-back tandem colonoscopies by the same endoscopist using an Olympus 190 colonoscope. The first colonoscopy will be performed without automated polyp detection software (standard technique) followed immediately by another colonoscopy with automated polyp detection software (combination technique).
Back-to-back tandem colonoscopies by the same endoscopist using an Olympus 190 colonoscope. In this arm, the first colonoscopy with be performed with automated polyp detection software (combination technique) followed immediately by another colonoscopy without automated polyp detection software (standard technique)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04074577
Brief Title
Computer Aided Detection, Tandem Colonoscopy Study
Official Title
Computer Aided Detection, Tandem Colonoscopy Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
September 17, 2020 (Actual)
Primary Completion Date
October 14, 2020 (Actual)
Study Completion Date
October 14, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Diseases
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Technique followed by Combination
Arm Type
Active Comparator
Arm Description
Back-to-back tandem colonoscopies by the same endoscopist using an Olympus 190 colonoscope. The first colonoscopy will be performed without automated polyp detection software (standard technique) followed immediately by another colonoscopy with automated polyp detection software (combination technique).
Arm Title
Combination +followed by Standard Technique
Arm Type
Active Comparator
Arm Description
Back-to-back tandem colonoscopies by the same endoscopist using an Olympus 190 colonoscope. In this arm, the first colonoscopy with be performed with automated polyp detection software (combination technique) followed immediately by another colonoscopy without automated polyp detection software (standard technique)
Intervention Type
Diagnostic Test
Intervention Name(s)
Standard technique First
Intervention Description
colonoscopy without automated polyp detection software
Intervention Type
Diagnostic Test
Intervention Name(s)
combination technique First
Intervention Description
automated polyp detection software
Primary Outcome Measure Information:
Title
Number of adenomas detected in combination technique compared to adenomas detected in standard technique Measured by Adenoma Miss Rate (AMR)
Description
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.
Time Frame
1 Year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seth Gross, MD
Organizational Affiliation
New York Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Computer Aided Detection, Tandem Colonoscopy Study
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