Performance Evaluation of the NaviAid™ G-Eye System
40 Years
N/A
Both
Colorectal Cancer, Polyp, Adenoma
Trial Information
Performance Evaluation of the NaviAid™ G-Eye System
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 multicenter, two-arm, randomized, open-label study intended to compare the
additional diagnostic yield obtained by performing NaviAid™ G-Eye procedure vs. the
diagnostic yield obtained by performing standard colonoscopy procedure.
Subjects will be randomized to one of two groups: Group A, the "Study Group," and Group B,
the "Control Group."
Group A: Subjects will undergo a complete standard colonoscopy as the first procedure.
Immediately after the standard colonoscopy procedure, a complete NaviAid™ G-Eye procedure
will be performed by the same endoscopist.
Group B: Subjects will undergo a complete NaviAid™ G-Eye procedure as the first procedure.
Immediately after the NaviAid™ G-Eye procedure, a complete standard colonoscopy will be
performed by the same endoscopist.
Inclusion Criteria:
- The patient is undergoing colonoscopy for screening, for surveillance in follow-up of
previous polypectomy or for diagnostic workup;
- The patient is over 40 years old;
- The patient must understand and provide written consent for the procedure.
Exclusion Criteria:
- Subjects with inflammatory bowel disease;
- Subjects with a personal history of polyposis syndrome;
- Subjects with suspected chronic stricture potentially precluding complete
colonoscopy;
- Subjects with 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:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
The purpose of this study is to compare the additional diagnostic yield obtained by performing NaviAid™ G-Eye procedure vs. the diagnostic yield obtained by performing standard colonoscopy procedure.
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:
No
Principal Investigator
Erwin Santo, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Tel-Aviv Sourasky Medical Center
Authority:
Israel: Ethics Commission
Study ID:
G-Eye 15501
NCT ID:
NCT01552200
Start Date:
June 2012
Completion Date:
April 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
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