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

Not Applicable

• Conditions: Adenoma; Polyps; Colorectal Cancer
• Interventions: Device: G-EYE™ Colonoscopy; Device: Standard Colonoscopy

• Registration Number: NCT02545699
• Lead Sponsor: Smart Medical Systems Ltd.

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.

Study Timeline

• Study First Submitted: 2015-08-31
• Study Start: 2015-09
• Study First Submitted QC: 2015-09-07
• Study First Posted: 2015-09-10
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-05
• Last Update Posted: 2016-06-07
• Primary Completion: 2017-06
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 350

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
G-EYE™ Colonoscopy	G-EYE™ Colonoscopy	G-EYE™ Colonoscopy
Standard Colonoscopy	Standard Colonoscopy	Standard Colonoscopy

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Safety (number of patients with adverse events)	48-72 hours
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

Trial Locations

Locations (1)

Bnai Zion Hospital; 🇮🇱 Haifa, Israel