NCT04979962

Brief Summary

This study is intended to demonstrate the superiority of colorectal polyp detection using computer-assisted colonoscopy compared to conventional colonoscopy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,162

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 28, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

November 24, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 21, 2022

Completed
Last Updated

September 18, 2023

Status Verified

September 1, 2023

Enrollment Period

10 months

First QC Date

July 19, 2021

Last Update Submit

September 15, 2023

Conditions

Polyp ColorectalAdenoma Colon

Outcome Measures

Primary Outcomes (1)

  • Adenoma per colonoscopy (APC)

    Total number of histologically confirmed adenomas and carcinomas detected in the colonoscopy divided by the total number of colonoscopies

    1 day/procedure

Secondary Outcomes (2)

  • Positive predictive value (PPV)

    1 day/procedure

  • Adenoma detection rate (ADR)

    1 day/procedure

Study Arms (2)

CAC Group

EXPERIMENTAL

Inspection with computer assisted colonoscopy.

Device: EW10-EC02 (Endoscopy Support Program)

CC Group

NO INTERVENTION

Inspection with conventional colonoscopy

Interventions

EW10-EC02 (Endoscopy Support Program)DEVICE

EW10-EC02 is intended to automatically detect the location of suspected polyps in colonoscopy exams. Identified polyps are highlighted to the clinician in real-time during the exam, as a video image superimposed on the endoscope monitor. EW10-EC02 is limited to the detection of suspected findings, and should not be used in lieu of full patient evaluation or relied upon to make or confirm a diagnosis.

CAC Group

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Average risk subjects undergoing their first colonoscopy (screening) or follow-up colonoscopy for previous history of polyps (surveillance interval of 3 years or greater)
  • Patients aged 45 or older
  • Patients who can provide an informed consent

You may not qualify if:

  • Patients with history of colon resection, Inflammatory Bowel Disease (IBD), Familial Adenomatous Polyposis (FAP), severe comorbidity, including end-stage cardiovascular/pulmonary/liver/renal disease
  • Patients who are pregnant or are planning pregnancy during study period
  • Patients who are not able to or refuse to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Keck Medicine University of Southern California

Los Angeles, California, 90033, United States

Location

Largo Medical Center (HCA)

Largo, Florida, 33770, United States

Location

Brigham and Women's Hospital

Chestnut Hill, Massachusetts, 02467, United States

Location

GI Associates

Flowood, Mississippi, 39232, United States

Location

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States

Location

Kansas City VA Medical Center

Kansas City, Missouri, 64128, United States

Location

New York University/Manhattan Endoscopy

New York, New York, 10016, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

Swedish Medical Center

Seattle, Washington, 98104, United States

Location

Related Publications (1)

  • Desai M, Ausk K, Brannan D, Chhabra R, Chan W, Chiorean M, Gross SA, Girotra M, Haber G, Hogan RB, Jacob B, Jonnalagadda S, Iles-Shih L, Kumar N, Law J, Lee L, Lin O, Mizrahi M, Pacheco P, Parasa S, Phan J, Reeves V, Sethi A, Snell D, Underwood J, Venu N, Visrodia K, Wong A, Winn J, Wright CH, Sharma P. Use of a Novel Artificial Intelligence System Leads to the Detection of Significantly Higher Number of Adenomas During Screening and Surveillance Colonoscopy: Results From a Large, Prospective, US Multicenter, Randomized Clinical Trial. Am J Gastroenterol. 2024 Jul 1;119(7):1383-1391. doi: 10.14309/ajg.0000000000002664. Epub 2024 Jan 18.

    PMID: 38235741DERIVED

Study Officials

  • Prateek Sharma, MD

    Kansas City VA Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Patients will be randomized 1:1, inspection with computer assisted colonoscopy: inspection with conventional colonoscopy.
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2021

First Posted

July 28, 2021

Study Start

November 24, 2021

Primary Completion

September 30, 2022

Study Completion

November 21, 2022

Last Updated

September 18, 2023

Record last verified: 2023-09

Locations

US(10)