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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02545699
• Other study ID #: G-EYE 15507
• Status: Recruiting
• Phase: N/A
• First received: August 31, 2015
• Last updated: June 5, 2016
• Start date: September 2015
• Est. completion date: June 2017

Study information

• Verified date: June 2016
• Source: Smart Medical Systems Ltd.
• Contact: Tova Rainis, Dr.
• Phone: 04-8359426
• Email: tovarainis[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Adenoma
• Colorectal Cancer
• Polyps

Intervention

Device:
• G-EYE™ Colonoscopy
G-EYE™ Colonoscopy
• Standard Colonoscopy
Standard Colonoscopy

Locations

Country	Name	City	State
Israel	Bnai Zion Hospital	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Smart Medical Systems Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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)	No
Secondary	Procedure times		At time of procedure	No
Secondary	Safety (number of patients with adverse events)		48-72 hours	Yes