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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01917513
Other study ID # G-EYE 15505
Secondary ID
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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)
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