Performance Evaluation of the NaviAid™ G-Eye System

NCT ID: NCT01552200

Last Updated: 2014-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2013-06-30

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.

Conditions

Colorectal Cancer; Polyp; Adenoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

A-Standard Colonoscopy, G-Eye procedure

Standard Colonoscopy,G-Eye procedure

Group Type: EXPERIMENTAL

Group A-Standard Colonoscopy, then NaviAid™ G-Eye procedure

Intervention Type: PROCEDURE

Standard Colonoscopy,NaviAid™ G-Eye procedure

B- G-Eye procedure, Standard Colonoscopy

G-Eye procedure,Standard Colonoscopy

Group Type: ACTIVE_COMPARATOR

Group B-NaviAid™ G-Eye procedure, then Standard Colonoscopy

Intervention Type: PROCEDURE

G-Eye procedure, Standard Colonoscopy

Interventions

Group A-Standard Colonoscopy, then NaviAid™ G-Eye procedure

Standard Colonoscopy,NaviAid™ G-Eye procedure

Intervention Type: PROCEDURE

Group B-NaviAid™ G-Eye procedure, then Standard Colonoscopy

G-Eye procedure, Standard Colonoscopy

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Smart Medical Systems Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erwin Santo, MD

Role: PRINCIPAL_INVESTIGATOR

Tel-Aviv Sourasky Medical Center

Beny Shpak, MD

Role: PRINCIPAL_INVESTIGATOR

Laniado Hospital

Yael Kopelman, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Locations

St. Marienkrankenhaus Frankfurt

Frankfurt, , Germany

Hadassah Medical Organization

Jerusalem, , Israel

Laniado Hospital

Netanya, , Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Countries

Germany; Israel

References

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.

Reference Type: DERIVED

PMID: 25704662 (View on PubMed)

Other Identifiers

G-Eye 15501

Identifier Type: -

Identifier Source: org_study_id