Real-time Computer-Aided Detection of Colonic Adenomas With NEC WISE VISION® Endoscopy

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT05611151

Studienbeginn:
April 2023

Letztes Update:
20.03.2024

Wirkstoff:
-

Indikation (Clinical Trials):
Adenoma, Colonic Polyps

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
NEC Corporation

Collaborator:
Meditrial Europe Ltd., Meditrial USA Inc.,

Studienleiter

Hitoshi Ikeda
Study Director
NEC Corporation

Kontakt

Monica Tocchi, MD, PhD
Kontakt:
Phone: +1 646 933 1025
E-Mail: m.tocchi@meditrial.net» Kontaktdaten anzeigen

Studienlocations
(3 von 5)

GastroZentrum Lippe
Bad Salzuflen
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Helmut Neumann, MD» Ansprechpartner anzeigen

Kansas City VA Hospital
64128 Kansas City
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Prateek Sharma, MD» Ansprechpartner anzeigen

Humanitas Mater Domini
Castellanza
ItalyRekrutierend» Google-Maps
Ansprechpartner:
Benedetto Mangiavillano, Prof.» Ansprechpartner anzeigen

Humanitas Research Hospital
20089 Milan
ItalyRekrutierend» Google-Maps
Ansprechpartner:
Alessandro Repici, Prof.» Ansprechpartner anzeigen

Portsmouth Hospitals University NHS Trust, Cosham
PO6 3LY Portsmouth
United KingdomRekrutierend» Google-Maps
Ansprechpartner:
Pradeep Bhandari, Prof.» Ansprechpartner anzeigen

Alle anzeigen

Studien-Informationen

Detailed Description:

This study aims to evaluate whether NEC WISE VISION® Endoscopy enhances the ability to detect

mucosal lesions when compared with the current standard-of-care procedure (high-definition

white light [HDWL] colonoscopy). The CADe device, Wise VISION® Endoscopy, contains an

artificial intelligence/machine learning (AI/ML) advanced algorithm to aid the endoscopists

in detection of colonic lesions.

This study plans to enrol 830 subjects aged ≥ 45 years and < 75 years, who are scheduled for

screening or surveillance colonoscopy.

After review of the inclusion and exclusion criteria, eligible subjects will be randomized in

a 1:1 ratio to receive either computer-aided colonoscopy (CADe Group) or standard colonoscopy

without CADe (Standard Colonoscopy Group).

All adenomas, that are identified during the colonoscopies, will be removed and biopsied as

per standard clinical practice to assess adenoma miss rate, polyp miss rate, adenomas per

colonoscopy and other endpoints.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Patient is presenting to the endoscopy unit for colon cancer screening or surveillance

colonoscopy.

- Signed Informed Consent

Exclusion Criteria:

1. Contraindications to colonoscopy

2. Colonoscopy within the previous three (3) years

3. High-risk indications for colonoscopy

4. Antithrombotic therapy that cannot be stopped, precluding polyp resection

5. Inflammatory bowel disease

6. Referred for endoscopic mucosal resection (EMR)

7. Familial adenomatous polyposis syndrome or Serrated Polyposis Syndrome

8. Pregnant or planning a pregnancy during the study period

Studien-Rationale

Primary outcome:

1. Adenomas per Colonoscopy (APC) (Time Frame - during the procedure/surgery):
Total number of histologically confirmed adenomas resected divided by the total number of colonoscopies.

Studien-Arme

Experimental: CADe Colonoscopy
CADe Colonoscopy: Patient undergoes WISE VISION® Endoscopy CADe colonoscopy
Active Comparator: HDWL Colonoscopy
HDWL Colonoscopy: Patient undergoes HDWL colonoscopy without CADe

Geprüfte Regime

Computer Aided Detection (CADe):
Computer-aided detection (CADe) devices are used in conjunction with colonoscopy to aid in the detection of lesions in the gastrointestinal tract.

Quelle: ClinicalTrials.gov

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