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

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer; Adenoma; Polyps
• Intervention / Treatment: Device: Standard Colonoscopy; Device: G-EYE™ 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 Type: Interventional
• Enrollment (Anticipated): 350
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tova Rainis, Dr.; Phone Number: 04-8359426; Email: tovarainis@gmail.com

Study Locations

• Israel
  • Haifa, Israel
    • Recruiting
    • Bnai Zion Hospital
    • Contact: Tova Rainis
    • Principal Investigator: Tova Rainis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Colonoscopy	Device: Standard Colonoscopy; Standard Colonoscopy
Experimental: G-EYE™ Colonoscopy	Device: G-EYE™ Colonoscopy; G-EYE™ Colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Smart Medical Systems Ltd.
• Investigators: Principal Investigator: Tova Rainis, Dr., Bnai Zion Medical Center

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Anticipated): June 1, 2017
• Study Completion (Anticipated): June 1, 2017

Study Registration Dates

• First Submitted: August 31, 2015
• First Submitted That Met QC Criteria: September 7, 2015
• First Posted (Estimate): September 10, 2015

Study Record Updates

• Last Update Posted (Estimate): June 7, 2016
• Last Update Submitted That Met QC Criteria: June 5, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Colonoscopy; Adenoma; CRC; Polyp; Detection Yield
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Adenoma
• Other Study ID Numbers: G-EYE 15507