Clinical trial NCT01552200: Performance Evaluation of the NaviAid™ G-Eye System
Official title: Performance Evaluation of the NaviAid™ G-Eye System
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: 2012-03-13
Enrollment: 126
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: 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.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: NaviAid™ G-Eye procedure adenoma detection rate compared to the standard colonoscopy procedure adenoma detection rate
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: Frankfurt
country: Germany
facility: St. Marienkrankenhaus Frankfurt
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
city: Netanya
country: Israel
facility: Laniado Hospital
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
Study officials:
affiliation: Tel-Aviv Sourasky Medical Center
name: Erwin Santo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Laniado Hospital
name: Beny Shpak, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hadassah Medical Organization
name: Yael Kopelman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Halpern Z, Gross SA, Gralnek IM, Shpak B, Pochapin M, Hoffman A, Mizrahi M, Rochberger YS, Moshkowitz M, Santo E, Melhem A, Grinshpon R, Pfefer J, Kiesslich R. Comparison of adenoma detection and miss rates between a novel balloon colonoscope and standard colonoscopy: a randomized tandem study. Endoscopy. 2015 Mar;47(3):238-44. doi: 10.1055/s-0034-1391437. Epub 2015 Feb 17.