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

This study is currently recruiting participants.
Verified December 2012 by Smart Medical Systems Ltd.
Sponsor:
Information provided by (Responsible Party):
Smart Medical Systems Ltd.
ClinicalTrials.gov Identifier:
NCT01749722
First received: November 11, 2012
Last updated: December 13, 2012
Last verified: December 2012
History of Changes
  Purpose

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


Condition Intervention
Colorectal Cancer
Polyp
Adenoma
 Device: NaviAid™ G-Eye procedure

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Safety and Efficacy of the NaviAid™ G-Eye System During Colonoscopy

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    To evaluate the safety of using the NaviAid™ G-Eye system during Colonoscopy


Estimated Enrollment: 50
Study Start Date: November 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NaviAid™ G-Eye procedure
NaviAid™ G-Eye procedure
 Device: NaviAid™ G-Eye procedure
NaviAid™ G-Eye procedure
Other Name: NaviAid™ G-Eye procedure

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.

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01749722

Locations
Israel
Elisha Hospital Recruiting
Haifa, Israel, 34636
Contact: Ian M Gralnek, Prof.     972-4-8309011     i_gralnek@rambam.health.gov.il    
Principal Investigator: Ian M Gralnek, Prof.            
Elisha Hospital Recruiting
Haifa, Israel, 34636
Contact: Alain Suissa, Dr.     +972-4-8309011     a_suissa@rambam.health.gov.il    
Sub-Investigator: Alain Suissa, Dr.            
Sponsors and Collaborators
Smart Medical Systems Ltd.
Investigators
Principal Investigator: Ian M Gralnek, Prof. Elisha Hospital
  More Information

No publications provided

Responsible Party: Smart Medical Systems Ltd.
ClinicalTrials.gov Identifier: NCT01749722     History of Changes
Other Study ID Numbers: G-Eye 15502
Study First Received: November 11, 2012
Last Updated: December 13, 2012
Health Authority: Israel: Ethics Commission

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

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

ClinicalTrials.gov processed this record on May 16, 2013