EAGLE Trial CADDIE Artificial Intelligence Endoscopy

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

Rekrutierend

NCT-Nummer:
NCT05730192

Studienbeginn:
Mai 2023

Letztes Update:
28.09.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Adenoma, Colonic Polyps

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Odin Medical

Collaborator:
Meditrial Europe Ltd.

Studienleiter

Alessandro Repici, Prof.
Principal Investigator
Humanitas Research Hospital

Kontakt

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

Studienlocations
(3 von 10)

Brustzentrum im Sana Klinikum Lichtenberg
Fanningerstraße 32
10365 Berlin
DeutschlandRekrutierend» Google-Maps
Ansprechpartner:
Siegbert Faiss, Prof, Dr.» Ansprechpartner anzeigen

Israeli-Georgian Medical Research Clinic Healthycore
Tbilisi
GeorgiaRekrutierend» Google-Maps
Ansprechpartner:
Nana Kiknadze, Dr.» Ansprechpartner anzeigen

Humanitas Mater Domini
21100 Castellanza
ItalyRekrutierend» Google-Maps
Ansprechpartner:
Benedetto Mangiavillano, Prof.» Ansprechpartner anzeigen

Humanitas Catania
95045 Catania
ItalyRekrutierend» Google-Maps
Ansprechpartner:
Giacomo Bonanno, Dr.» Ansprechpartner anzeigen

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

H-T. Centrum Medyczne
43-100 Tychy
PolandRekrutierend» Google-Maps
Ansprechpartner:
Tomasz Romańczyk, Dr n. med.» Ansprechpartner anzeigen

The Maria Sklodowska-Curie National Research Institute of Oncology
00-001 Warsaw
PolandRekrutierend» Google-Maps
Ansprechpartner:
Michał Kamiński, Prof.» Ansprechpartner anzeigen

Przychodnia Polskiej Fundacji Gastroenterologii
00-631 Warsaw
PolandRekrutierend» Google-Maps
Ansprechpartner:
Bronisław Kotowski, Dr.» Ansprechpartner anzeigen

University Hospital "Clinico Lozano Blesa" of Zaragoza
Zaragoza
SpainRekrutierend» Google-Maps
Ansprechpartner:
Angel Lanas, Prof, Dr.» Ansprechpartner anzeigen

University College Hospital London
London
United KingdomZurückgezogen» Google-Maps

Alle anzeigen

Studien-Informationen

Detailed Description:

The EAGLE study will be conducted with a parallel design. Patients who meet the study

inclusion/exclusion criteria will be randomized in a 1:1 ratio to receive either

computer-aided colonoscopy (CADDIE Arm) using CADDIE or standard colonoscopy without CADe

(Control Arm). All resected polyps will be submitted for histologic examination.

Ein-/Ausschlusskriterien

Inclusion Criteria:

1. Screening or surveillance colonoscopy

2. Age 40 years or older

3. Informed consent

Exclusion Criteria:

1. Emergency colonoscopies

2. Inflammatory bowel disease (IBD)

3. Colorectal Cancer (CRC)

4. Previous Colorectal Cancer (CRC)

5. Previous colonic resection

6. Returning for a planned elective therapeutic colonoscopy.

7. Polyposis syndromes (familial adenomatous polyposis)

8. Contraindication for biopsy or polypectomy.

Studien-Rationale

Primary outcome:

1. Number of Adenoma per colonoscopy (APC) (Time Frame - During the procedure/surgery):
Superiority of CADDIE Arm vs. control.

2. Positive percent agreement (PPA) (Time Frame - During the procedure/surgery):
Non inferiority of CADDIE Arm vs. control.

Studien-Arme

Experimental: CADDIE colonoscopy (CADDIE Arm)
CADDIE is a computer-assisted detection (CADe) device used in conjunction with endoscopy for the detection of abnormal lesions in the gastrointestinal tract.
Active Comparator: Standard high-definition white light colonoscopy (Control Arm)
Patients will receive a standard colonoscopy

Geprüfte Regime

CADDIE (Colonoscopy):
A colonoscopy is an examination of the bowels using a colonoscope, or a thin, flexible tube with a light and camera. It can help identify issues like colorectal cancer, polyps, and ulcers.

Quelle: ClinicalTrials.gov

Sie können folgenden Inhalt einem Kollegen empfehlen:

"EAGLE Trial CADDIE Artificial Intelligence Endoscopy"

Bitte tragen Sie auch die Absenderdaten vollständig ein, damit Sie der Empfänger erkennen kann.

Die mit (*) gekennzeichneten Angaben müssen eingetragen werden!