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

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

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Adenoma; Polyp
• Intervention / Treatment: Device: NaviAid™ G-Eye 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 single-center, non randomized open-label study intended to evaluate the serious adverse events prevalence when using the NaviAid™ G-Eye system during colonoscopy.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel, 34636
    • Elisha hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: NaviAid™ G-Eye procedure	Device: NaviAid™ G-Eye procedure; NaviAid™ G-Eye procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of adverse events	To evaluate the safety of using the NaviAid™ G-Eye system during Colonoscopy	Subjects will be followed during the study period (approximatly 3 hours) and follow up will be done within 48-72 hours following the procedure

Collaborators and Investigators

• Sponsor: Smart Medical Systems Ltd.
• Investigators: Principal Investigator: Ian M Gralnek, Prof., Elisha hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (ACTUAL): April 1, 2013
• Study Completion (ACTUAL): June 1, 2013

Study Registration Dates

• First Submitted: November 11, 2012
• First Submitted That Met QC Criteria: December 13, 2012
• First Posted (ESTIMATE): December 17, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): July 30, 2013
• Last Update Submitted That Met QC Criteria: July 29, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: Colorectal Cancer; Colonoscopy; Adenoma; Polyp; Detection Rate; NaviAid™ G-Eye procedure; NaviAid™ G-Eye system; G-Eye procedure; G-Eye system
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Adenoma
• Other Study ID Numbers: G-Eye 15502