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

40 Years
75 Years
Open (Enrolling)
Colorectal Cancer, Polyp, Adenoma

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Trial Information

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

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

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.

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

Exclusion Criteria:

- Subjects with inflammatory bowel disease;

- Subjects with a personal history of polyposis syndrome;

- Subjects with suspected colonic stricture potentially precluding complete

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Number of adverse events

Outcome Description:

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

Outcome 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

Safety Issue:


Principal Investigator

Ian M Gralnek, Prof.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Elisha Hospital


Israel: Ethics Commission

Study ID:

G-Eye 15502



Start Date:

November 2012

Completion Date:

March 2013

Related Keywords:

  • Colorectal Cancer
  • Polyp
  • Adenoma
  • Colorectal Cancer
  • Polyp
  • Adenoma
  • Detection Rate
  • Colonoscopy
  • NaviAid™ G-Eye procedure
  • NaviAid™ G-Eye system
  • G-Eye procedure
  • G-Eye system
  • Adenoma
  • Colorectal Neoplasms
  • Polyps