JOURNAL ONKOLOGIE – STUDIE

Comparing Detection of Standard Colonoscopy, CAD-EYE and Combined CAD-EYE and G-EYE® Aided Colonoscopy

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

Rekrutierend

NCT-Nummer:
NCT05237310

Studienbeginn:
Februar 2022

Letztes Update:
08.03.2022

Wirkstoff:
-

Indikation (Clinical Trials):
Colorectal Neoplasms, Adenoma

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Smart Medical Systems Ltd.

Collaborator:
Fujifilm

Studienleiter

Ralf Kiesslich, Prof.
Principal Investigator
Helios Dr. Horst Schmidt Kliniken Wiesbaden GmbH

Kontakt

Ralf Kiesslich, Prof.
Kontakt:
Phone: +49 611 43-9002
E-Mail: Ralf.Kiesslich@helios-gesundheit.de» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Helios Dr. Horst Schmidt Kliniken Wiesbaden GmbH
65199 Wiesbaden
(Hessen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Ralf Kiesslich, Prof.
Phone: +49 611 43-9002
E-Mail: Ralf.Kiesslich@helios-gesundheit.de» Ansprechpartner anzeigen

Studien-Informationen

Detailed Description:

The purpose of this study is to compare the additional diagnostic yield over Standard

Colonoscopy (i.e., the adenoma miss-rate reduction) obtained by performing CADEYE and G-EYE®

aided colonoscopy, vs. the additional diagnostic yield over Standard Colonoscopy (i.e., the

adenoma miss-rate reduction) obtained by performing CAD-EYE aided colonoscopy. This is a

single-center, four-arm dual-tandem, randomized, open-label study intended to compare the

additional detection yield beyond standard colonoscopy obtained by performing combined

CAD-EYE and G-EYE® high definition colonoscopy vs. the additional detection yield beyond

standard colonoscopy obtained by performing CAD-EYE high definition colonoscopy. Consecutive

adult subjects who were referred for elective colonoscopy will be asked to enroll into this

randomized clinical study if the candidate meets the study inclusion and exclusion criteria

Ein-/Ausschlusskriterien

Inclusion Criteria:

1. Screening and surveillance population for Adenoma and CRC.

2. Subjects age is at least 18 years

3. The patient must understand and sign a written informed consent for the procedure.

Exclusion Criteria:

1. Subjects with inflammatory bowel disease;

2. Subjects with a personal history of hereditary polyposis syndrome;

3. Subjects with suspected chronic stricture potentially precluding complete colonoscopy;

4. Subjects with diverticulitis or toxic megacolon;

5. Subjects with prior colonic surgery (exclusion appendectomy)

6. Subjects with a history of radiation therapy to abdomen or pelvis;

7. Pregnant or lactating female subjects;

8. Subjects who are currently enrolled in another clinical investigation.

9. Subjects with current oral or parenteral use of anticoagulants, not considered

eligible by the investigator.

10. Subjects with recent (within the last 3 mounts) coronary ischemia or CVA (stroke)

11. Any patient condition deemed too risky for the study by the investigator

Studien-Rationale

Primary outcome:

1. Additional Adenoma Detection (Time Frame - Upon histology results (up to 30 days)):
Additional adenoma detection yield (represented by the miss rate) of CAD-EYE and G-EYE® colonoscopy over standard colonoscopy compared to the additional adenoma detection yield of CAD-EYE aided colonoscopy over standard colonoscopy

Studien-Arme

Active Comparator: Standard Colonoscopy followed by CAD-EYE
Subjects will undergo standard colonoscopy immediately followed by CAD-EYE colonoscopy (both procedures performed by the same endoscopist in the same sedation session).
Active Comparator: CAD-EYE followed by Standard Colonoscopy
Subjects will undergo CAD-EYE colonoscopy immediately followed by standard colonoscopy (both procedures performed by the same endoscopist in the same sedation session).
Active Comparator: Standard Colonoscopy followed by combined CAD-EYE and G-EYE colonoscopy
Subjects will undergo standard colonoscopy immediately followed by combined CAD-EYE and G-EYE colonoscopy (both procedures performed by the same endoscopist in the same sedation session).
Active Comparator: Combined CAD-EYE and G-EYE colonoscopy followed by Standard Colonoscopy
Subjects will undergo combined CAD-EYE and G-EYE colonoscopy immediately followed by standard colonoscopy (both procedures performed by the same endoscopist in the same sedation session).

Geprüfte Regime

Standard Colonoscopy:
Standard Colonoscopy using a standard Fujifilm colonoscope
G-EYE Colonoscopy:
G-EYE Colonoscopy performed using SMART Medical G-EYE Colonoscope
CAD-EYE:
Colonoscopy performed using with the aid of Fujifilm CAD-EYE artificial intelligence

Quelle: ClinicalTrials.gov

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