Comparison of Colonoscopy Adenoma Detection Yield

NCT05158725 | Unknown

• 1 other identifier: G-EYE/Discovery
• Study Type: interventional
• Target: 1,320
• Locations: 1 country
• Sites: 1

Brief Summary

A Prospective Randomized Comparison of colonoscopy Adenoma Detection Yield of (i) Standard Colonoscopy (SC), (ii) artificial intelligence (Discovery) aided colonoscopy, and (iii) artificial intelligence (Discovery) and permanently mounted balloon (G-EYE®) aided colonoscopy.

Conditions

Adenoma Colon

Outcome Measures

Primary Outcomes (1)

• Adenoma detection yield

  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

  Upon histology results (up to 30 days)

Secondary Outcomes (3)

• Adenoma Detection Rate (Discovery + G-EYE vs. Standard Colonoscopy)

  Upon histology results (up to 30 days)

• Adenoma Detection Rate (Discovery vs. Standard Colonosocopy)

  Upon histology results (up to 30 days)

• Adenoma Per Colonoscopy (Discovery vs. Discovery + G-EYE)

  Upon histology results (up to 30 days)

Study Arms (3)

Standard Colonoscopy

ACTIVE COMPARATOR

Subjects will undergo colonoscopy using a standard colonoscope

Device: Standard Colonoscopy

Discovery aided colonoscopy

ACTIVE COMPARATOR

Subjects will undergo colonoscopy using a a standard colonoscope and the Discovery aided colonoscopy

Device: Discovery aided colonoscopy

Discovery and G-EYE aided colonoscopy

EXPERIMENTAL

Subjects will undergo colonoscopy using the G-EYE Endoscope and the Discovery aided colonoscopy

Device: Discovery and G-EYE

Interventions

Standard Colonoscopy DEVICE

In this arm, subjects will undergo colonoscopy using a standard colonoscope

Standard Colonoscopy

Discovery aided colonoscopy DEVICE

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 aided colonoscopy

Discovery and G-EYE DEVICE

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

Discovery and G-EYE aided colonoscopy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Screening and surveillance population for Adenoma and CRC.
• 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

• Dr. Horst Schmidt Klinik GmbH: lead

Study Sites (1)

Helios Dr. Horst Schmidt Kliniken Wiesbaden GmbH

Wiesbaden, 65199, Germany

RECRUITING

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

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: December 15, 2021
• Study Start: November 8, 2021
• Primary Completion: May 1, 2022
• Study Completion: June 1, 2022
• Last Updated: December 15, 2021

Record last verified: 2021-12

Locations

DE (1)