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

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ClinicalTrials.gov Identifier: NCT01917513
Recruitment Status : Completed
First Posted : August 6, 2013
Results First Posted : January 23, 2018
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
Smart Medical Systems Ltd.

Brief 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

Condition or disease Intervention/treatment Phase
Adenoma Polyps Colorectal Cancer Device: G-EYE™ colonoscopy Device: Standard Colonoscopy Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Actual Study Start Date : May 2014
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Detection Rate of Adenomas and Serrated Lesions [ Time Frame: Approximalty following 14 days (histology results) ]
    The percentage of patients with at least one adenoma or serrated lesion in the G-EYE™ group will be compared to the Standard group


Secondary Outcome Measures :
  1. Number of Polyp and Adenoma Detection, Procedure Times and Safety (Number of Patients With Adverse Events. [ Time Frame: Up to 14 days (histology results) ]
    The secondary outcome is a composite-each of the measured parameters will be reported as a single value for each arm



Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01917513


Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center, Harvard Medical School
Boston, Massachusetts, United States, 02115
United States, New York
NYU Langone Medical Center
New York, New York, United States, 10016
Denmark
Herlev Hospital
Harlev, Denmark, 2730
Germany
Universitätsmedizin Johannes Gutenberg University Mainz
Mainz, Germany, 55131
Universitätsklinikum Tübingen
Tübingen, Germany, D-72076
Helios Dr. Horst Schmidt Kliniken (HSK)
Wiesbaden, Germany, 65199
India
Asian Institute of Gastroenterology
Hyderabad, India
Israel
Hadassah Medical Center
Jerusalem, Israel, 91999
Laniado Hospital
Netanya, Israel
Assaf Harofeh Medical Center
Tzrifin, Israel, 70300
Italy
Vita Salute San Raffaele University - Scientific Institute San Raffaele
Milan, Italy, 20132
Netherlands
Maastricht University Medical Centre
Maastricht, Netherlands, 6202AZ
Radboud UMC
Nijmegen, Netherlands, 6500 HB
United Kingdom
Birmingham City University
Birmingham, United Kingdom
Russells Hall Hospital
Dudley, United Kingdom
Sponsors and Collaborators
Smart Medical Systems Ltd.
Investigators
Principal Investigator: Ralf Kiesslich, Prof. Helios Dr. Horst Schmidt Kliniken, Wiesbaden, Germany
  Study Documents (Full-Text)

Documents provided by Smart Medical Systems Ltd.:
Study Protocol  [PDF] July 9, 2013


Responsible Party: Smart Medical Systems Ltd.
ClinicalTrials.gov Identifier: NCT01917513     History of Changes
Other Study ID Numbers: G-EYE 15505
First Posted: August 6, 2013    Key Record Dates
Results First Posted: January 23, 2018
Last Update Posted: January 23, 2018
Last Verified: December 2017

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