Safety and Efficacy of the NaviAid™ G-Eye System During Colonoscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01749722
Recruitment Status : Completed
First Posted : December 17, 2012
Last Update Posted : July 30, 2013
Information provided by (Responsible Party):
Smart Medical Systems Ltd.

Brief Summary:
To evaluate the safety of using the NaviAid™ G-Eye system during Colonoscopy

Condition or disease Intervention/treatment Phase
Colorectal Cancer Polyp Adenoma Device: NaviAid™ G-Eye procedure Not Applicable

Detailed Description:

Colonoscopy is the gold-standard method for CRC screening, as it enables detection and real-time removal of pre-cancerous polyps during the examination. It is well known that lesions are missed during routine colonoscopy.5 major reasons can be detailed for missing polyps during colonoscopy: polyps that are hidden behind folds, polyps that are masked by the colon's topography and natural folds, shallow polyps, unscreened portions of the colon (due to incomplete colonoscopy) and endoscope slippage. The NaviAid™ G-Eye system presents a unique concept that overcomes all 5 items listed above, providing an overall solution to the two endoscopy key challenges of limited detection/treatment yield and limited operation range.

The G-Eye endoscope comprises a standard endoscope onto which a unique balloon is permanently integrated, at its bending section. The NaviAid™ G-Eye may be used for performing controlled withdrawal and endoscope stabilization.

A major attribute of the NaviAid™ G-Eye system controlled withdrawal technique of the endoscope, with the balloon moderately inflated is to expand and stretch the intestinal lumen during endoscope withdrawal.

This is a single-center, non randomized open-label study intended to evaluate the serious adverse events prevalence when using the NaviAid™ G-Eye system during colonoscopy.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Safety and Efficacy of the NaviAid™ G-Eye System During Colonoscopy
Study Start Date : November 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

Arm Intervention/treatment
Experimental: NaviAid™ G-Eye procedure
NaviAid™ G-Eye procedure
Device: NaviAid™ G-Eye procedure
NaviAid™ G-Eye procedure

Primary Outcome Measures :
  1. Number of adverse events [ Time Frame: Subjects will be followed during the study period (approximatly 3 hours) and follow up will be done within 48-72 hours following the procedure ]
    To evaluate the safety of using the NaviAid™ G-Eye system during Colonoscopy

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • The patient is undergoing colonoscopy for screening, for surveillance of previous colon polyp(s) or for diagnostic evaluation.
  • The patient is 40-75 years old;
  • The patient must understand and provide written informed consent for the procedure.

Exclusion Criteria:

  • Subjects with inflammatory bowel disease;
  • Subjects with a personal history of polyposis syndrome;
  • Subjects with suspected colonic stricture potentially precluding complete colonoscopy;
  • Subjects with active diverticulitis or toxic megacolon;
  • Subjects with a history of radiation therapy to abdomen or pelvis;
  • Pregnant or lactating female subjects;
  • Subjects who are currently enrolled in another clinical investigation.
  • Subjects with routine oral or parenteral use of anticoagulants
  • Subjects with recent (within the last 3 mounts) coronary ischemia or CVA (stroke)
  • Any patient condition deemed too risky for the study by the investigator

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 identifier (NCT number): NCT01749722

Elisha Hospital
Haifa, Israel, 34636
Sponsors and Collaborators
Smart Medical Systems Ltd.
Principal Investigator: Ian M Gralnek, Prof. Elisha Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Smart Medical Systems Ltd. Identifier: NCT01749722     History of Changes
Other Study ID Numbers: G-Eye 15502
First Posted: December 17, 2012    Key Record Dates
Last Update Posted: July 30, 2013
Last Verified: July 2013

Keywords provided by Smart Medical Systems Ltd.:
Colorectal Cancer
Detection Rate
NaviAid™ G-Eye procedure
NaviAid™ G-Eye system
G-Eye procedure
G-Eye system

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