NCT01552200

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P25-P50 for not_applicable colorectal-cancer

Timeline
Completed

Started Jun 2012

Shorter than P25 for not_applicable colorectal-cancer

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 6, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 13, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

April 8, 2014

Status Verified

April 1, 2014

Enrollment Period

1 year

First QC Date

March 6, 2012

Last Update Submit

April 6, 2014

Conditions

Colorectal CancerPolypAdenoma

Keywords

Colorectal CancerPolypAdenomaDetection RateColonoscopyNaviAid™ G-Eye procedureNaviAid™ G-Eye systemG-Eye procedureG-Eye system

Outcome Measures

Primary Outcomes (1)

  • NaviAid™ G-Eye procedure adenoma detection rate compared to the standard colonoscopy procedure adenoma detection rate

    Subjects will be followed during the study period (approximatly 3 hours) and follow up will be done within 48-72 hours following the procedure

Study Arms (2)

A-Standard Colonoscopy, G-Eye procedure

EXPERIMENTAL

Standard Colonoscopy,G-Eye procedure

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

B- G-Eye procedure, Standard Colonoscopy

ACTIVE COMPARATOR

G-Eye procedure,Standard Colonoscopy

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

Interventions

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

Standard Colonoscopy,NaviAid™ G-Eye procedure

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

G-Eye procedure, Standard Colonoscopy

B- G-Eye procedure, Standard Colonoscopy

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

St. Marienkrankenhaus Frankfurt

Frankfurt, 60318, Germany

Location

Hadassah Medical Organization

Jerusalem, 91120, Israel

Location

Laniado Hospital

Netanya, 42150, Israel

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Related Publications (1)

  • 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.

    PMID: 25704662DERIVED

MeSH Terms

Conditions

Colorectal NeoplasmsPolypsAdenoma

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Erwin Santo, MD

    Tel-Aviv Sourasky Medical Center

    PRINCIPAL INVESTIGATOR

  • Beny Shpak, MD

    Laniado Hospital

    PRINCIPAL INVESTIGATOR

  • Yael Kopelman, MD

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2012

First Posted

March 13, 2012

Study Start

June 1, 2012

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

April 8, 2014

Record last verified: 2014-04

Locations

DE(1)IL(3)