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

NCT05237310 | Unknown

• 1 other identifier: G-EYE 15076
• Study Type: interventional
• Target: 372
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Cancer; Adenoma

Keywords

G-EYE; Colonoscopy; CAD-EYE; Adenoma; Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Additional Adenoma Detection

  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

  Upon histology results (up to 30 days)

Study Arms (4)

Standard Colonoscopy followed by CAD-EYE

ACTIVE COMPARATOR

Subjects will undergo standard colonoscopy immediately followed by CAD-EYE colonoscopy (both procedures performed by the same endoscopist in the same sedation session).

Device: Standard Colonoscopy; Device: CAD-EYE

CAD-EYE followed by Standard Colonoscopy

ACTIVE COMPARATOR

Subjects will undergo CAD-EYE colonoscopy immediately followed by standard colonoscopy (both procedures performed by the same endoscopist in the same sedation session).

Device: Standard Colonoscopy; Device: CAD-EYE

Standard Colonoscopy followed by combined CAD-EYE and G-EYE colonoscopy

ACTIVE COMPARATOR

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).

Device: Standard Colonoscopy; Device: G-EYE Colonoscopy; Device: CAD-EYE

Combined CAD-EYE and G-EYE colonoscopy followed by Standard Colonoscopy

ACTIVE COMPARATOR

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).

Device: Standard Colonoscopy; Device: G-EYE Colonoscopy; Device: CAD-EYE

Interventions

Standard Colonoscopy DEVICE

Standard Colonoscopy using a standard Fujifilm colonoscope

CAD-EYE followed by Standard Colonoscopy; Combined CAD-EYE and G-EYE colonoscopy followed by Standard Colonoscopy; Standard Colonoscopy followed by CAD-EYE; Standard Colonoscopy followed by combined CAD-EYE and G-EYE colonoscopy

G-EYE Colonoscopy DEVICE

G-EYE Colonoscopy performed using SMART Medical G-EYE Colonoscope

Combined CAD-EYE and G-EYE colonoscopy followed by Standard Colonoscopy; Standard Colonoscopy followed by combined CAD-EYE and G-EYE colonoscopy

CAD-EYE DEVICE

Colonoscopy performed using with the aid of Fujifilm CAD-EYE artificial intelligence

CAD-EYE followed by Standard Colonoscopy; Combined CAD-EYE and G-EYE colonoscopy followed by Standard Colonoscopy; Standard Colonoscopy followed by CAD-EYE; Standard Colonoscopy followed by combined CAD-EYE and G-EYE colonoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Screening and surveillance population for Adenoma and CRC.
• Subjects age is at least 18 years
• The patient must understand and sign a written informed consent for the procedure.

You may not qualify if:

• Subjects with inflammatory bowel disease;
• Subjects with a personal history of hereditary polyposis syndrome;
• Subjects with suspected chronic stricture potentially precluding complete colonoscopy;
• Subjects with diverticulitis or toxic megacolon;
• Subjects with a history of radiation therapy to abdomen or pelvis;
• Pregnant or lactating female subjects;
• Subjects who are currently enrolled in another clinical investigation.
• Subjects with current oral or parenteral use of anticoagulants, not considered eligible by the investigator.
• Subjects with recent (within the last 3 mounts) coronary ischemia or CVA (stroke)
• Any patient condition deemed too risky for the study by the investigator

Sponsors & Collaborators

• Smart Medical Systems Ltd.: lead
• Fujifilm: collaborator

Study Sites (1)

Helios Dr. Horst Schmidt Kliniken Wiesbaden GmbH

Wiesbaden, 65199, Germany

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Adenoma

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Ralf Kiesslich, Prof.

  Helios Dr. Horst Schmidt Kliniken Wiesbaden GmbH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ralf Kiesslich, Prof.

CONTACT

+49 611 43-9002; Ralf.Kiesslich@helios-gesundheit.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects will be randomized to one of four groups (arms), Group A1, A2, B1 and B2: Group A1: Subjects will undergo standard colonoscopy immediately followed by CAD-EYE colonoscopy (both procedures performed by the same endoscopist in the same sedation session). Group A2: Subjects will undergo CAD-EYE colonoscopy immediately followed by standard colonoscopy (both procedures performed by the same endoscopist in the same sedation session). Group B1: 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). Group B2: 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).

Study Record Dates

• First Submitted: February 2, 2022
• First Posted: February 14, 2022
• Study Start: February 2, 2022
• Primary Completion: August 1, 2022
• Study Completion: September 1, 2022
• Last Updated: March 8, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)