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CompletedNCT02066064Updated Feb 12, 2016

G-Eye Advanced Colonoscopy For Increased Polyp Detection Rate-randomized Tandem Study With Different Endoscopist

An interventional study of Standard Colonoscopy and G-EYE(TM) Colonoscopy in Colorectal Cancer and Adenoma, sponsored by Smart Medical Systems Ltd.. Completed at 1 site in Germany. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-02-12.

Sponsored by Smart Medical Systems Ltd. · Not applicable, Interventional, and Screening

Phase
Not applicable
Study type
Interventional
Enrollment
58
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study 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.

Read the detailed description

Single Center, two-arm, randomized , open-label study with different and blinded endoscopists.

02

Conditions studied

  • Colorectal Cancer
  • Adenoma

Keywords

  • Colorectal Cancer
  • Adenoma
  • Standard Colonoscopy
  • G-EYE(TM) Colonoscopy
03

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's enrollment of 58 is below the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Smart Medical Systems Ltd. is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Patients over 50 years old
  2. Referred to colonoscopy for screening, following positive FOBT testing, change of bowel habits or for surveillance colonoscopy (history of adenoma resection).
  3. The patient must understand and provide written consent for the procedure.

Exclusion criteria

Exclusion Criteria:

  1. Subjects with inflammatory bowel disease;
  2. Subjects with a personal history of polyposis syndrome;
  3. Subjects with suspected chronic stricture potentially precluding complete colonoscopy;
  4. Subjects with diverticulitis or toxic megacolon;
  5. Subjects with a history of radiation therapy to abdomen or pelvis;
  6. Pregnant or lactating female subjects;
  7. Subjects who are currently enrolled in another clinical investigation.
  8. Subjects with current oral or parenteral use of anticoagulants
  9. Subjects with recent (within the last 3 mounts) coronary ischemia or CVA (stroke)
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
58 participants (actual)

Study arms

  • Experimental
    Group A

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

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

  • Active comparator
    Group B

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

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

Interventions

  • ProcedureStandard Colonoscopy

    Standard Colonoscopy

  • ProcedureG-EYE(TM) Colonoscopy

    G-EYE(TM) Colonoscopy

06

What researchers measure

Primary outcomes

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

    Time frame: estimated 14 days (following histology results)

Secondary outcomes

  1. polyp and adenoma detection, procedure times and safety

    Time frame: 24-72 hours post procedure

07

Study locations

1 site
  • St. Marienkrankenhaus Frankfurt
    Frankfurt, 60318, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 12, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02066064
Lead sponsor
Smart Medical Systems Ltd.
Responsible party
Sponsor
First posted
Feb 19, 2014
Start date
Nov 2013
Primary completion
Dec 2015
Completion
Dec 2015
Last update
Feb 12, 2016

Study contacts

Ralf Kiesslich, Prof.
principal investigator

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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