NCT04555135 (ColonCADe) is a NA clinical trial of EndoVigilant Software in Colon Polyp, sponsored by EndoVigilant Inc.

Who is sponsoring NCT04555135?

NCT04555135 is sponsored by EndoVigilant Inc.

What drugs are being tested in NCT04555135?

Interventions in NCT04555135: EndoVigilant Software.

What condition does NCT04555135 study?

NCT04555135 studies Colon Polyp, Colon Neoplasm, Colon Adenoma.

Is NCT04555135 still recruiting?

NCT04555135 is currently terminated. Last updated 1 April 2022.

Last reviewed 2022-04-01 · How we verify

NCT04555135: ColonCADe

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Clinical Study To Measure The Effect Of Use Of Artificial Intelligence (AI) Enabled Computer Aided Detection (CADe) Assistance Software In Detecting Colon Polyps During Standard Colonoscopy Procedures

Terminated NA Last updated 1 April 2022

What this trial tests

NA trial testing EndoVigilant Software in Colon Polyp in 769 participants. Terminated before completion.

Timeline

28 September 2020

Primary endpoint
24 September 2021

30 November 2021

Quick facts

Lead sponsor	EndoVigilant Inc
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	diagnostic
Enrollment	769
Start date	28 September 2020
Primary completion	24 September 2021
Estimated completion	30 November 2021
Sites	4 locations across United States

Drugs / interventions tested

EndoVigilant Software

Conditions studied

Colon Polyp — all drugs for Colon Polyp →
Colon Neoplasm — all drugs for Colon Neoplasm →
Colon Adenoma — all drugs for Colon Adenoma →

Sponsor

EndoVigilant Inc

Who can join

45 and older, any sex, with Colon Polyp or Colon Neoplasm. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

EndoVigilant software device augments existing colonoscopy procedure video in real-time by highlighting colon polyps and mucosal abnormalities. It is intended to assist gastroenterologists in detection of adenomas and serrated polyps. The device is an adjunctive tool and is not intended to replace physicians' decision making related to detection, diagnosis or treatment. This study with an adaptive design measures the clinical benefit (increase in detection of adenomatous and serrated polyps) and increased risk (increased extraction of non-adenomas) during standard colonoscopy procedures when EndoVigilant software device is used.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Evaluation of Computer-Aided Detection During Colonoscopy in the Community (AI-SEE): A Multicenter Randomized Clinical Trial.
Wei MT, Shankar U, Parvin R, Abbas SH, et al · · 2023 · cited 49× · PMID 36892545 · DOI 10.14309/ajg.0000000000002239
Characterization of medical device randomized controlled trials with adaptive designs.
Su G, Shen D, Deng D, Bai Q, et al · · 2025 · cited 1× · PMID 39656083 · DOI 10.57264/cer-2024-0011

Verify or expand the search:

Other recruiting trials for Colon Polyp

Currently open trials in the same condition.

NCT06617468 — Effect of the Computer Aided Diagnosis with Explainable Artificial Intelligence for Colon Polyp on Optical Diagnosis and · NA · active not recruiting
NCT06496958 — Water Exchange and CO2 Insufflation With Abdominal Compression Device to Reduce Manual Assistance · NA · recruiting
NCT06073561 — Underwater Endoscopic Mucosal Resection · NA · recruiting
NCT05990218 — Artificial Intelligence in the Detection of Right Sided Colonic Polyp in Different Operator Experience · NA · recruiting
NCT05551052 — CRC Detection Reliable Assessment With Blood · active not recruiting

Other EndoVigilant Inc trials

Trials by the same sponsor.

NCT04195646 — Computer Aided Detection of Polyps During Colonoscopy Procedures · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04555135 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by EndoVigilant Inc
Last refreshed: 1 April 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04555135.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing