Clinical trial NCT01749722: Safety and Efficacy of the NaviAid™ G-Eye System During Colonoscopy
Official title: Safety and Efficacy of the NaviAid™ G-Eye System During Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Polyp
Adenoma
Keywords: Colorectal Cancer
Polyp
Adenoma
Detection Rate
Colonoscopy
NaviAid™ G-Eye procedure
NaviAid™ G-Eye system
G-Eye procedure
G-Eye system
Lead sponsor: Smart Medical Systems Ltd.
Sponsor class: INDUSTRY
First posted: 2012-12-17
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

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 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

Primary outcomes:
measure: Number of adverse events
timeFrame: Subjects will be followed during the study period (approximatly 3 hours) and follow up will be done within 48-72 hours following the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Elisha Hospital
Study officials:
affiliation: Elisha Hospital
name: Ian M Gralnek, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gralnek IM, Suissa A, Domanov S. Safety and efficacy of a novel balloon colonoscope: a prospective cohort study. Endoscopy. 2014 Oct;46(10):883-7. doi: 10.1055/s-0034-1377968. Epub 2014 Sep 16.