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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01917513
• Other study ID #: G-EYE 15505
• Status: Completed
• Phase: N/A
• First received: July 30, 2013
• Last updated: December 26, 2017
• Start date: May 2014
• Est. completion date: September 2016

Study information

• Verified date: December 2017
• Source: Smart Medical Systems Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• 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 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

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)

Related Conditions & MeSH terms

• Adenoma
• Colorectal Cancer
• Colorectal Neoplasms
• Polyps

Intervention

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

Locations

Country	Name	City	State
Denmark	Herlev Hospital	Harlev
Germany	Universitätsmedizin Johannes Gutenberg University Mainz	Mainz
Germany	Universitätsklinikum Tübingen	Tübingen
Germany	Helios Dr. Horst Schmidt Kliniken (HSK)	Wiesbaden
India	Asian Institute of Gastroenterology	Hyderabad
Israel	Hadassah Medical Center	Jerusalem
Israel	Laniado Hospital	Netanya
Israel	Assaf Harofeh Medical Center	Tzrifin
Italy	Vita Salute San Raffaele University - Scientific Institute San Raffaele	Milan
Netherlands	Maastricht University Medical Centre	Maastricht
Netherlands	Radboud UMC	Nijmegen
United Kingdom	Birmingham City University	Birmingham
United Kingdom	Russells Hall Hospital	Dudley
United States	Beth Israel Deaconess Medical Center, Harvard Medical School	Boston	Massachusetts
United States	NYU Langone Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Smart Medical Systems Ltd.

Countries where clinical trial is conducted

United States,  Denmark,  Germany,  India,  Israel,  Italy,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection Rate of Adenomas and Serrated Lesions	The percentage of patients with at least one adenoma or serrated lesion in the G-EYE™ group will be compared to the Standard group	Approximalty following 14 days (histology results)
Secondary	Number of Polyp and Adenoma Detection, Procedure Times and Safety (Number of Patients With Adverse Events.	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)