Plain English Summary
Background and study aims
A colonoscopy is a procedure used to examine the large bowel, the colon or the rectum. Colorectal cancer can be diagnosed using this type of procedure. The procedure involves the use of a device called a colonoscope. This study compares two devices and the aim is to assess which device will detect the highest number of precancerous lesions.
Who can participate?
Adult healthy volunteers over 50 referred for colonoscopy.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in group 1 undergo a colonoscopy using a standard colonosope. Those in group 2 undergo a colonoscopy using a G-EYE HD colonoscope.
What are the possible benefits and risks of participating?
Based on previous studies, use of the G-EYE colonoscope leads to improved detection of adenomas and serrated lesions. The G-EYE colonoscope is CE marked and used like any other colonoscope. Any complications that may result from the procedure are the same as those associated with a standard colonoscopy.
Where is the study run from?
A number of hospitals in Europe, Israel, India and the USA
When is the study starting and how long is it expected to run for?
May 2014 to January 2017
Who is funding the study?
Smart Medical Systems Ltd (Israel)
Who is the main contact?
Ms Avda Yoelzon
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT01917513
Protocol/serial number
G-EYE15505
Study information
Scientific title
Prospective randomized trial to compare the clinical efficiency (Adenoma Detection Rate) of G-EYE™ HD Colonoscopy with Standard HD Colonoscopy
Acronym
Study hypothesis
G-EYE™ HD colonoscopy detects substantially more adenomas and serrated lesions compared with Standard HD colonoscopy.
Ethics approval
Landesarzlekammer Hessen Ethics Committee, 13/01/2014, ref: FF133/2013
Study design
Randomized interventional multicentre open-label trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Colorectal cancer
Intervention
The trial contains two arms:
1. Investigational arm: G-EYE™ colonoscopy
2. Control arm: standard colonoscopy
Intervention type
Device
Phase
Drug names
Primary outcome measures
Adenomas and serrated lesions detection rate: the percentage of subjects with at least one adenoma or serrated lesion found in each of the study groups. Timepoint: up to 14 days following procedure (histology results)
Secondary outcome measures
1. Polyp and adenoma detection: number of polyps and adenomas detected. Timepoint: up to 14 days following procedure (histology results)
2. Procedural times: minutes. Timepoint: During the procedure
3. Safety: number and severity of adverse events. Timepoint: During the procedure, post procedure, during follow-up calls or during unscheduled visits of the subjects
Overall trial start date
26/05/2014
Overall trial end date
31/01/2017
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients over 50
2. Referred to colonoscopy for screening, following positive Fecal Occult Blood Test (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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
1000
Participant 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)
Recruitment start date
26/05/2014
Recruitment end date
21/09/2016
Locations
Countries of recruitment
Denmark, Germany, India, Israel, Italy, Netherlands, United Kingdom, United States of America
Trial participating centre
Hadassah Medical Center
Kiryat Hadassah, POB 12000
Jerusalem
91120
Israel
Trial participating centre
HSK, Dr. Horst Schmidt Kliniken GmbH
Ludwig-Erhard- Straße 100
Wiesbaden
65199
Germany
Trial participating centre
Russells Hall Hospital
Dudley
DY1 2HQ
United Kingdom
Trial participating centre
Copenhagen University Hospital Herlev
Herlev Ringvej 75
Herlev
2730
Denmark
Trial participating centre
Laniado Hospital
Kiryat Sanz
Netanya
42150
Israel
Trial participating centre
Universitätsklinikum Tübingen
Otfried-Müller-Str. 10
Tübingen
D-72076
Germany
Trial participating centre
San Raffaele Hospital - Milan
via Olgettina 60
Milano
20132
Italy
Trial participating centre
Maastricht University Medical Centre
Postbox 5800
Maastricht
6202 AZ
Netherlands
Trial participating centre
Assaf Harofe
Tzrifin
Tzrifin
70300
Israel
Trial participating centre
Asian Institute of Gastroenterology
6-3-661, Somajiguda
Hyderabad
500 082
India
Trial participating centre
NYU Langone Medical Center
333 E 38th St
New York
10016
United States of America
Trial participating centre
Universitätsmedizin Johannes Gutenberg University Mainz
Langenbeckstraße 1
Mainz
55131
Germany
Trial participating centre
Beth Israel Deaconess Medical Center
Harvard Medical School
330 Brookline Ave
Boston
02215
United States of America
Trial participating centre
UMC Radboud
Geert Grooteplein Zuid 10
Nijmegen
6525
Netherlands
Sponsor information
Organisation
Smart Medical Systems Ltd
Sponsor details
5 HaNofar St.
Ra'anana
4366404
Israel
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Smart Medical Systems Ltd (Israel)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The plan is to submit all of the results to medical journals in February - March 2017.
IPD sharing plan
The datasets generated during and/or analysed during the current study are/will be available upon request from Adva Yoselzon.
Intention to publish date
30/04/2017
Participant level data
Available on request
Results - basic reporting
Publication summary