Neoplasms

All Conditions

Symptoms and General Pathology

Adenoma

Polyps

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

G-EYE™ colonoscopy

Standard Colonoscopy

Ralf Kiesslich, Prof.

The purpose of this study is to compare the adenoma detection rate of G-EYE™ high definition colonoscopy with that of standard high definition colonoscopy

This is a multicenter, two-arm, randomized, open-label study intended to compare the detection rate obtained by performing G-EYE™ high definition colonoscopy vs. the detection rate obtained by performing high definition standard colonoscopy.

The study will enroll 1000 subjects. 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.

Subjects will sign informed consent form and undergo randomization. The study includes a run-in preliminary phase of 270 patients to allow physicians to get familiar with the G-EYE™ endoscope.

Prospective Trial to Compare the Clinical Efficiency of G-EYE™ HD Colonoscopy With Standard HD Colonoscopy

Prospective Randomized Trial to Compare the Clinical Efficiency (Adenoma Detection Rate) of G-EYE™ HD Colonoscopy With Standard HD Colonoscopy

The percentage of patients with at least one adenoma or serrated lesion in the G-EYE™ group will be compared to the Standard group

The secondary outcome is a composite-each of the measured parameters will be reported as a single value for each arm

Smart Medical Systems Ltd.

G-EYE™ colonoscopy

G-EYE™ colonoscopy: G-EYE™ colonoscopy

G-EYE™ Colonoscopy

Standard Colonoscopy

Standard Colonoscopy: Standard Colonoscopy

Patients in this group underwent standard high definition colonoscopy

Patients in this group underwent G-EYE™ high definition colonoscopy using using an insufflated balloon during withdrawal

Total

Age, Continuous

Sex: Female, Male

Prof. Ralf Kiesslich

Detection Rate of Adenomas and Serrated Lesions

Number of Polyp and Adenoma Detection, Procedure Times and Safety (Number of Patients With Adverse Events.

Overall Study

Tova Rainis, Dr.

Tova Rainis

The purpose of this study is to compare the adenoma detection rate (ADR) of the G-EYE™ colonoscopy with that of standard colonoscopy.

This is a single-center, two-arm , randomized, open-label study intended to compare the detection rate obtained by performing G-EYE™ colonoscopy vs. the detection rate obtained by performing standard colonoscopy.

The study will enroll 350 subjects. Consecutive adult subjects who were referred for elective colonoscopy will be asked to enroll in this randomized clinical study if the candidate meets the study inclusion and exclusion criteria.

Subjects will sign an informed consent form and undergo randomization.

Prospective Trial to Compare ADR of G-EYE™ Colonoscopy With Standard Colonoscopy

Prospective Randomized Trial to Compare the Adenoma Detection Rate of G-EYE™ Colonoscopy With Standard Colonoscopy

The secondary outcome is a composite- each of the measured parameters will be reported as a single value for each arm.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Prospective Trial to Compare the Clinical Efficiency of G-EYE™ HD Colonoscopy With Standard HD Colonoscopy	NCT01917513	Adenoma Polyps Colorectal Canc...	G-EYE™ colonosc... Standard Colono...	50 Years -	Smart Medical Systems Ltd.
Prospective Trial to Compare ADR of G-EYE™ Colonoscopy With Standard Colonoscopy	NCT02545699	Adenoma Polyps Colorectal Canc...	G-EYE™ Colonosc... Standard Colono...	50 Years -	Smart Medical Systems Ltd.
Prospective Trial to Compare ADR of G-EYE™ Colonoscopy With Standard Colonoscopy	NCT02545699	Adenoma Polyps Colorectal Canc...	G-EYE™ Colonosc... Standard Colono...	50 Years -	Smart Medical Systems Ltd.
Prospective Trial to Compare the Clinical Efficiency of G-EYE™ HD Colonoscopy With Standard HD Colonoscopy	NCT01917513	Adenoma Polyps Colorectal Canc...	G-EYE™ colonosc... Standard Colono...	50 Years -	Smart Medical Systems Ltd.

Spots Global Cancer Trial Database for detection yield