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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02545699

Enrollment

350

Registered

2015-09-10

Start date

2015-09-30

Completion date

2017-06-30

Last updated

2016-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenoma, Colorectal Cancer, Polyps

Keywords

Adenoma, Polyp, CRC, Colonoscopy, Detection Yield

Brief summary

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

Detailed description

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.

Interventions

DEVICEG-EYE™ Colonoscopy

G-EYE™ Colonoscopy

DEVICEStandard Colonoscopy

Standard Colonoscopy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

1. Patients over 50 years old 2. Referred to colonoscopy for screening, following positive FOBT testing, change of bowel habits, for diagnostic evaluation or for surveillance colonoscopy (history of adenoma resection). 3. The patient must understand and provide written consent for the procedure.

Exclusion criteria

1. Subjects with inflammatory bowel disease; 2. Subjects with a personal history of polyposis syndrome; 3. Subjects with suspected chronic stricture potentially precluding complete colonoscopy; 4. Subjects with diverticulitis or toxic megacolon; 5. Subjects with a history of radiation therapy to abdomen or pelvis; 6. Pregnant or lactating female subjects; 7. Subjects who are currently enrolled in another clinical investigation. 8. Subjects with current oral or parenteral use of anticoagulants that have not stopped using anticoagulants as required by the guidelines of the medical center; 9. Subjects with recent (within the last 3 mounts) coronary ischemia or CVA (stroke) 10. Any patient condition deemed too risky for the study by the investigator 11. Previous colonic surgery (except for appendectomy)

Design outcomes

Primary

Measure	Time frame
G-EYE™ Colonoscopy detection rate of adenomas and serrated lesions compared to the standard colonoscopy detection rate of the same	Approximately following 14 days (histology results)

Secondary

Measure	Time frame	Description
Polyp and adenoma detection	Up to 14 days (Histology results)	The secondary outcome is a composite- each of the measured parameters will be reported as a single value for each arm.
Procedure times	At time of procedure	—
Safety (number of patients with adverse events)	48-72 hours	—

Countries

Israel

Contacts

Primary ContactTova Rainis, Dr.

tovarainis@gmail.com04-8359426

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026