JOURNAL ONKOLOGIE – STUDIE

Comparison of Colonoscopy Adenoma Detection Yield

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

Rekrutierend

NCT-Nummer:
NCT05158725

Studienbeginn:
November 2021

Letztes Update:
15.12.2021

Wirkstoff:
-

Indikation (Clinical Trials):
Adenoma

Geschlecht:
Alle

Altersgruppe:
Alle

Phase:
-

Sponsor:
Dr. Horst Schmidt Klinik GmbH

Collaborator:
-

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:

Multi-center, three-arm, randomized, controlled, open-label study.

Total of up to 1320 patients will be randomized, including up to 10% for subject drop-out,

440 to each of the three following arms (groups):

Group 1 (1st arm): patients will receive standard colonoscopy (SC) Group 2 (2nd arm):

patients will receive colonoscopy aided by the Discovery artificial intelligence software

(DC) Group 3 (3rd arm): patients will receive colonoscopy aided by the Discovery artificial

intelligence software and the G-EYE® balloon (GDC) The purpose of this study is to compare

between the diagnostic yield of Standard Colonoscopy, Discovery aided colonoscopy, and

Discovery & G-EYE® aided colonoscopy.

Ein-/Ausschlusskriterien

Inclusion Criteria:

1. Screening and surveillance population for Adenoma and CRC.

2. 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. Adenoma detection yield (Time Frame - Upon histology results (up to 30 days)):
adenoma detection yield, represented by Adenoma Per Colonoscopy (APC), of Standard Colonoscopy, compared with APC of Discovery aided colonoscopy and further compared with APC of Discovery & G-EYE® aided colonoscopy

Secondary outcome:

1. Adenoma Detection Rate (Discovery + G-EYE vs. Standard Colonoscopy) (Time Frame - Upon histology results (up to 30 days)):
Adenoma Detection Rate of Discovery and G-EYE® aided colonoscopy compared to Adenoma Detection Rate of Standard Colonoscopy

2. Adenoma Detection Rate (Discovery vs. Standard Colonosocopy) (Time Frame - Upon histology results (up to 30 days)):
Adenoma Detection Rate of Discovery aided colonoscopy compared to Adenoma Detection Rate of Standard Colonoscopy

3. Adenoma Per Colonoscopy (Discovery vs. Discovery + G-EYE) (Time Frame - Upon histology results (up to 30 days)):
Adenoma Per Colonoscopy of Discovery aided colonoscopy compared to Adenoma Per Colonoscopy of Discovery and G-EYE® aided colonoscopy

Studien-Arme

Active Comparator: Standard Colonoscopy
Subjects will undergo colonoscopy using a standard colonoscope
Active Comparator: Discovery aided colonoscopy
Subjects will undergo colonoscopy using a a standard colonoscope and the Discovery aided colonoscopy
Experimental: Discovery and G-EYE aided colonoscopy
Subjects will undergo colonoscopy using the G-EYE Endoscope and the Discovery aided colonoscopy

Geprüfte Regime

Standard Colonoscopy:
In this arm, subjects will undergo colonoscopy using a standard colonoscope
Discovery aided colonoscopy:
the Discovery is a customized detection support software, developed utilizing AI deep learning technology to support endoscopic lesion detection in the colon. In this arm, a standard colonoscope is used with the Discovery.
Discovery and G-EYE:
The G-EYE® Endoscope is a standard colonoscope which is remanufactured by installing the G-EYE® balloon on the distal bending section of the colonoscope. in this arm, the G-EYE® Endoscope is used with the Discovery

Quelle: ClinicalTrials.gov

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