Performance Evaluation of the NaviAid™ G-Eye System

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Smart Medical Systems Ltd.
ClinicalTrials.gov Identifier:
NCT01552200
First received: March 6, 2012
Last updated: April 6, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Colorectal Cancer
Polyp
Adenoma
Procedure: Group A-Standard Colonoscopy, then NaviAid™ G-Eye procedure
Procedure: Group B-NaviAid™ G-Eye procedure, then Standard Colonoscopy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Performance Evaluation of the NaviAid™ G-Eye System

Resource links provided by NLM:


Further study details as provided by Smart Medical Systems Ltd.:

Primary Outcome Measures:
  • NaviAid™ G-Eye procedure adenoma detection rate compared to the standard colonoscopy procedure adenoma detection rate [ Time Frame: Subjects will be followed during the study period (approximatly 3 hours) and follow up will be done within 48-72 hours following the procedure ] [ Designated as safety issue: No ]

Enrollment: 126
Study Start Date: June 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A-Standard Colonoscopy, G-Eye procedure
Standard Colonoscopy,G-Eye procedure
Procedure: Group A-Standard Colonoscopy, then NaviAid™ G-Eye procedure
Standard Colonoscopy,NaviAid™ G-Eye procedure
Active Comparator: B- G-Eye procedure, Standard Colonoscopy
G-Eye procedure,Standard Colonoscopy
Procedure: Group B-NaviAid™ G-Eye procedure, then Standard Colonoscopy
G-Eye procedure, Standard 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 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

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01552200

Locations
Germany
St. Marienkrankenhaus Frankfurt
Frankfurt, Germany, 60318
Israel
Hadassah Medical Organization
Jerusalem, Israel, 91120
Laniado Hospital
Netanya, Israel, 42150
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239
Sponsors and Collaborators
Smart Medical Systems Ltd.
Investigators
Principal Investigator: Erwin Santo, MD Tel-Aviv Sourasky Medical Center
Principal Investigator: Beny Shpak, MD Laniado Hospital
Principal Investigator: Yael Kopelman, MD Hadassah Medical Organization
  More Information

No publications provided

Responsible Party: Smart Medical Systems Ltd.
ClinicalTrials.gov Identifier: NCT01552200     History of Changes
Other Study ID Numbers: G-Eye 15501
Study First Received: March 6, 2012
Last Updated: April 6, 2014
Health Authority: Israel: Ethics Commission

Keywords provided by Smart Medical Systems Ltd.:
Colorectal Cancer
Polyp
Adenoma
Detection Rate
Colonoscopy
NaviAid™ G-Eye procedure
NaviAid™ G-Eye system
G-Eye procedure
G-Eye system

Additional relevant MeSH terms:
Adenoma
Colorectal Neoplasms
Polyps
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on April 21, 2014