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 July 2014 by Smart Medical Systems Ltd.
Sponsor:
Information provided by (Responsible Party):
Smart Medical Systems Ltd.
ClinicalTrials.gov Identifier:
NCT01917513
First received: July 30, 2013
Last updated: July 20, 2014
Last verified: July 2014
  Purpose

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
Adenoma
Polyps
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: March 2015
Estimated Primary Completion Date: December 2014 (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 250 patients to allow physicians to get familiar with the G-EYE™ endoscope.

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT01917513

Contacts
Contact: Ralf Kiesslich, Prof. (069) 1563-1287 R.Kiesslich@katharina-kasper.de

Locations
Denmark
Herlev Hospital Recruiting
Harlev, Denmark, 2730
Principal Investigator: Jacob Hendel, Dr.         
Sub-Investigator: Peter Thielsen, Dr.         
Germany
University of Erlangen-Nuremberg Recruiting
Erlangen, Germany, 91054
Contact: Helmut Neumann, Prof.       Helmut.Neumann@uk-erlangen.de   
Principal Investigator: Helmut Neumann, Prof.         
St. Marienkrankenhaus Frankfurt Recruiting
Frankfurt, Germany, 60318
Contact: Ralf Kiesslich, Prof.    (069) 1563-1287    R.Kiesslich@katharina-kasper.de   
Principal Investigator: Ralf Kiesslich, Prof.         
Sub-Investigator: Arthur Hoffman, Dr.         
Israel
Hadassah Ein Kerem Recruiting
Jerusalem, Israel
Contact: Julia Epshtein, Dr.    972-2-6776951    juliae@hadassah.org.il   
Principal Investigator: Julia Epshtein, Dr.         
Poland
COPERNICUS Podmiot Leczniczy Sp. z o.o. (Ltd.) Not yet recruiting
Gdańsk, Poland, 80-803
Principal Investigator: Marek Dobosz, Dr.         
Spain
Hospital Universitario Central de Asturias Not yet recruiting
Oviedo, Spain, 33006
Contact: Adolfo Suárez González, Dr.    985108000 ext 38392    adolfo.suarez@hcabuenes.es   
Principal Investigator: Adolfo Suárez González, Dr.         
United Kingdom
Russells Hall Hospital Not yet recruiting
Dudley, United Kingdom
Contact: Sauid Ishaq, Dr.    +44 1384 456111    Sauid.Ishaq@dgh.nhs.uk   
Principal Investigator: Sauid Ishaq, Dr.         
Sponsors and Collaborators
Smart Medical Systems Ltd.
Investigators
Principal Investigator: Ralf Kiesslich, Prof. St. Marienkrankenhaus Frankfurt, Frankfurt, Germany
  More Information

No publications provided

Responsible Party: Smart Medical Systems Ltd.
ClinicalTrials.gov Identifier: NCT01917513     History of Changes
Other Study ID Numbers: G-EYE 15505
Study First Received: July 30, 2013
Last Updated: July 20, 2014
Health Authority: Germany: Ethics Commission
United Kingdom: National Health Service
Spain: Ethics Committee

Keywords provided by Smart Medical Systems Ltd.:
Adenoma
Polyps
CRC
Colonoscopy
Detection Yield

Additional relevant MeSH terms:
Colorectal Neoplasms
Adenoma
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on October 01, 2014