Safety and Efficacy of the NaviAid™ G-Eye System During Colonoscopy
40 Years
75 Years
Both
Colorectal Cancer, Polyp, Adenoma
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
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.
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
Type of Study:
Interventional
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:
Yes
Principal Investigator
Ian M Gralnek, Prof.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Elisha Hospital
Authority:
Israel: Ethics Commission
Study ID:
G-Eye 15502
NCT ID:
NCT01749722
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
Name | Location |
|---|
