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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Smart Medical Systems Ltd.
ClinicalTrials.gov Identifier:
NCT01917513
First received: July 30, 2013
Last updated: October 25, 2016
Last verified: October 2016
  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


Enrollment: 1000
Study Start Date: May 2014
Primary Completion Date: October 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.

  Eligibility

Ages Eligible for Study:   50 Years and older   (Adult, Senior)
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

Locations
Denmark
Herlev Hospital
Harlev, Denmark, 2730
Germany
University of Erlangen-Nuremberg
Erlangen, Germany, 91054
University Clinic Tubingen
Tubingen, Germany, D-72076
HSK, Dr. Horst Schmidt Kliniken GmbH
Wiesbaden, Germany, 65199
Israel
Hadassah Ein Kerem
Jerusalem, Israel
Laniado Hospital
Netanya, Israel
Assaf Harofeh Medical Center
Zerifin, Israel, 70300
Italy
San Raffaele Hospital
Milan, Italy, 20132
Netherlands
Maastricht University Medical Centre
Maastricht, Netherlands, 6202AZ
University Medical Center Utrecht
Utrecht, Netherlands, 3508GA
United Kingdom
Russells Hall Hospital
Dudley, United Kingdom
Sponsors and Collaborators
Smart Medical Systems Ltd.
Investigators
Principal Investigator: Ralf Kiesslich, Prof. St. Marienkrankenhaus Frankfurt, Frankfurt, Germany
  More Information

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: October 25, 2016
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 December 05, 2016