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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01749722
• Other study ID #: G-Eye 15502
• Status: Completed
• Phase: N/A
• First received: November 11, 2012
• Last updated: July 29, 2013
• Start date: November 2012
• Est. completion date: June 2013

Study information

• Verified date: July 2013
• Source: Smart Medical Systems Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Adenoma
• Colorectal Cancer
• Colorectal Neoplasms
• Polyp

Intervention

Device:
• NaviAid™ G-Eye procedure
NaviAid™ G-Eye procedure

Locations

Country	Name	City	State
Israel	Elisha Hospital	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Smart Medical Systems Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes