NCT02066064

Brief Summary

The purpose of this study is to compare the adenoma detection rate of G-EYE™ high definition colonoscopy with that of standard high definition colonoscopy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable colorectal-cancer

Timeline
Completed

Started Nov 2013

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

November 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 19, 2014

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

February 12, 2016

Status Verified

February 1, 2016

Enrollment Period

2.1 years

First QC Date

February 10, 2014

Last Update Submit

February 11, 2016

Conditions

Colorectal CancerAdenoma

Keywords

Colorectal CancerAdenomaStandard ColonoscopyG-EYE(TM) Colonoscopy

Outcome Measures

Primary Outcomes (1)

  • G-EYE™ colonoscopy detection rate of adenomas and serrated lesions compared to the standard colonoscopy detection rate of the same.

    estimated 14 days (following histology results)

Secondary Outcomes (1)

  • polyp and adenoma detection, procedure times and safety

    24-72 hours post procedure

Study Arms (2)

Group A

EXPERIMENTAL

Subjects will undergo complete standard colonoscopy, followed by G-EYE(TM) Colonoscopy

Procedure: Standard ColonoscopyProcedure: G-EYE(TM) Colonoscopy

Group B

ACTIVE COMPARATOR

Subject will undergo G-EYE(TM) colonoscopy followed by standard colonoscopy

Procedure: Standard ColonoscopyProcedure: G-EYE(TM) Colonoscopy

Interventions

Standard ColonoscopyPROCEDURE

Standard Colonoscopy

Group AGroup B
G-EYE(TM) ColonoscopyPROCEDURE

G-EYE(TM) Colonoscopy

Group AGroup B

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients over 50 years old
  • Referred to colonoscopy for screening, following positive FOBT testing, change of bowel habits or for surveillance colonoscopy (history of adenoma resection).
  • 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 current oral or parenteral use of anticoagulants
  • Subjects with recent (within the last 3 mounts) coronary ischemia or CVA (stroke)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Marienkrankenhaus Frankfurt

Frankfurt, 60318, Germany

Location

MeSH Terms

Conditions

Colorectal NeoplasmsAdenoma

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Ralf Kiesslich, Prof.

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 10, 2014

First Posted

February 19, 2014

Study Start

November 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

February 12, 2016

Record last verified: 2016-02

Locations

DE(1)