Safety and Efficacy of the Olympus CADe System in Real-time Colonoscopy

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

Rekrutierend

NCT-Nummer:
NCT05943288

Studienbeginn:
April 2023

Letztes Update:
05.04.2024

Wirkstoff:
-

Indikation (Clinical Trials):
Colorectal Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Olympus Europe SE & Co. KG

Collaborator:
Cromsource

Studienleiter

Karolin Boecker
Study Director
Olympus Europa SE & Co. KG

Kontakt

Karolin Boecker
Kontakt:
Phone: +49 171 5531717
E-Mail: karolin.boecker@olympus.com» Kontaktdaten anzeigen

Studienlocations
(3 von 6)

Evangelisches Krankenhaus Düsseldorf
40217 Düsseldorf
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps

Leberkrebszentrum Universitätsklinikum Ulm
Albert-Einstein-Allee 23
89081 Ulm
DeutschlandRekrutierend» Google-Maps

ZU Leuven
3000 Leuven
BelgiumRekrutierend» Google-Maps

Fundación Biomédica Galicia Sur
36071 Pontevedra
SpainAktiv, nicht rekrutierend» Google-Maps

Hospital Universitari I Politécnic La Fe
46026 Valencia
SpainNoch nicht rekrutierend» Google-Maps

Linköping Universitetssjukhus
58185 Linköping
SwedenRekrutierend» Google-Maps

Alle anzeigen

Studien-Informationen

Detailed Description:

This Study aims to provide insight into whether the application of Artificial Intelligence

(Olympus Endoscopy Computer-Aided Detection (CADe) system) increases the detection rate of

adenomatous polyps in screening and / or surveillance colonoscopy procedures.

Ein-/Ausschlusskriterien

Inclusion Criteria:

1. Signed informed consent

2. 45-80 years

3. Undergoing colonoscopy for primary CRC screening or postpolypectomy surveillance

Exclusion Criteria:

1. Lack of informed written consent

2. History of CRC or inflammatory bowel disease or polyposis syndrome / familial

adenomatous polyposis coli (FAP)

3. Prior failed colonoscopy

- multiple historic prior failed colonoscopy due to poor bowel preparation OR

- a single prior failed colonoscopy due to reasons other than poor bowel

preparation

4. Biopsy/anesthesia/sedation contraindications

5. History of radio- and/or chemotherapy

6. Concurrent participation in another competing clinical study

Studien-Rationale

Primary outcome:

1. Adenoma Detection Rate (ADR) (Time Frame - During procedure):
Proportion of patients with at least one histologically confirmed adenoma (including advanced adenomas) or carcinoma in the CADe assisted colonoscopy (CADe+ arm) versus conventional colonoscopy without CAD (CADe- arm).

2. Positive Predictive Value (PPV) (Time Frame - During procedure):
Number of histologically confirmed polyps (i.e. adenomas, SSLs, or large (>10mm) hyperplastic polyps divided by the total number of resections.

Secondary outcome:

1. Adenoma Per Colonoscopy (APC) (Time Frame - During procedure):
Number of histologically proven adenomas (including advanced adenomas) or carcinomas divided by the total number of colonoscopies

2. Total Procedure Time (Time Frame - During procedure):
Time from procedure start (insertion of the colonoscope) until colon inspection during a typical withdrawal from cecum to rectosigmoid including any time needed for interventional procedures (biopsies, resection).

3. Endoscope withdrawal time (Time Frame - During procedure):
Time from deepest point of insertion (cecum) needed for complete inspection of the colon, excluding time spent on therapeutic intervention.

Studien-Arme

CADe +
Olympus Endoscopy Computer-Aided Detection (CADe) system
CADe -
Standard of Care Endoscopy (HD Whitelight)

Geprüfte Regime

OIP-1:
Olympus Endoscopy Computer-Aided Detection (CADe) system

Quelle: ClinicalTrials.gov

Sie können folgenden Inhalt einem Kollegen empfehlen:

"Safety and Efficacy of the Olympus CADe System in Real-time Colonoscopy"

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

Die mit (*) gekennzeichneten Angaben müssen eingetragen werden!