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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2016 by Smart Medical Systems Ltd.
Information provided by (Responsible Party):
Smart Medical Systems Ltd. Identifier:
First received: July 30, 2013
Last updated: February 11, 2016
Last verified: February 2016
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

Condition Intervention
Colorectal Cancer
Device: G-EYE™ colonoscopy
Device: Standard Colonoscopy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Prospective Randomized Trial to Compare the Clinical Efficiency (Adenoma Detection Rate) of G-EYE™ HD Colonoscopy With Standard HD Colonoscopy

Resource links provided by NLM:

Further study details as provided by Smart Medical Systems Ltd.:

Primary Outcome Measures:
  • G-EYE™ colonoscopy detection rate of adenomas and serrated lesions compared to the standard colonoscopy detection rate of the same. [ Time Frame: Approximalty following 14 days (histology results) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of polyp and adenoma detection, procedure times and safety (number of patients with adverse events. [ Time Frame: Up to 14 days (histology results) ] [ Designated as safety issue: Yes ]
    The secondary outcome is a composite-each of the measured parameters will be reported as a single value for each arm

Estimated Enrollment: 1000
Study Start Date: May 2014
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: G-EYE™ colonoscopy
G-EYE™ colonoscopy
Device: G-EYE™ colonoscopy
G-EYE™ colonoscopy
Active Comparator: Standard Colonoscopy
Standard Colonoscopy
Device: Standard Colonoscopy
Standard Colonoscopy

Detailed 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.


Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01917513

Contact: Ralf Kiesslich, Prof. (069) 1563-1287

Herlev Hospital Recruiting
Harlev, Denmark, 2730
Principal Investigator: Jacob Hendel, Dr.         
Sub-Investigator: Peter Thielsen, Dr.         
NHC Strasbourg Not yet recruiting
Strasbourg, France
Contact: Michael Delvaux, Dr.    33 388 11 67 68   
Principal Investigator: Michael Delvaux, Dr.         
University of Erlangen-Nuremberg Recruiting
Erlangen, Germany, 91054
Contact: Helmut Neumann, Prof.   
Principal Investigator: Helmut Neumann, Prof.         
University Clinic Tubingen Recruiting
Tubingen, Germany, D-72076
Contact: Martin Gotz    07071 - 29 - 85877   
Principal Investigator: Martin Gotz, Prof.         
HSK, Dr. Horst Schmidt Kliniken GmbH Recruiting
Wiesbaden, Germany, 65199
Contact: Ralf Kiesslich, Prof.    (069) 1563-1287   
Principal Investigator: Ralf Kiesslich, Prof.         
Sub-Investigator: Arthur Hoffman, Dr.         
Hadassah Ein Kerem Recruiting
Jerusalem, Israel
Contact: Julia Epshtein, Dr.    972-2-6776951   
Principal Investigator: Julia Epshtein, Dr.         
Laniado Hospital Recruiting
Netanya, Israel
Contact: Beni Shpak, Dr.    972-9-8604792   
Principal Investigator: Beni Shpak, Dr.         
Assaf Harofeh Medical Center Recruiting
Zerifin, Israel, 70300
Contact: Haim Shirin, PhD, MD   
Principal Investigator: Haim Shirin, PhD         
San Raffaele Hospital Recruiting
Milan, Italy, 20132
Contact: Pier A Testoni, Prof.    02.2643.2756   
Principal Investigator: Pier A Testoni, Prof.         
Maastricht University Medical Centre Not yet recruiting
Maastricht, Netherlands, 6202AZ
Contact: Silvia Sanduleanu, Dr.   
Principal Investigator: Silvia Sanduleanu, Dr.         
University Medical Center Utrecht Not yet recruiting
Utrecht, Netherlands, 3508GA
Contact: Peter D Siersema, Prof.   
Principal Investigator: Peter D Siersema, PhD         
Hospital Universitario Central de Asturias Not yet recruiting
Oviedo, Spain, 33006
Contact: Adolfo Suárez González, Dr.    985108000 ext 38392   
Principal Investigator: Adolfo Suárez González, Dr.         
Bezmi Alem University Not yet recruiting
Istanbul, Turkey
Contact: Hakan Senturk, PhD    0 (212) 453 1700   
Principal Investigator: Hakan Senturk, PhD         
United Kingdom
Russells Hall Hospital Recruiting
Dudley, United Kingdom
Contact: Sauid Ishaq, Dr.    +44 1384 456111   
Principal Investigator: Sauid Ishaq, Dr.         
Sponsors and Collaborators
Smart Medical Systems Ltd.
Principal Investigator: Ralf Kiesslich, Prof. St. Marienkrankenhaus Frankfurt, Frankfurt, Germany
  More Information

Responsible Party: Smart Medical Systems Ltd. Identifier: NCT01917513     History of Changes
Other Study ID Numbers: G-EYE 15505 
Study First Received: July 30, 2013
Last Updated: February 11, 2016
Health Authority: Germany: Ethics Commission
United Kingdom: National Health Service
Spain: Ethics Committee

Keywords provided by Smart Medical Systems Ltd.:
Detection Yield

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial processed this record on May 05, 2016