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Completed

NCT Number: NCT02066064

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

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.

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Key information

Conditions

Colorectal Cancer Adenoma Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Rectal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Marienkrankenhaus Frankfurt

Frankfurt, 60318, Germany

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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 current oral or parenteral use of anticoagulants
  • Subjects with recent (within the last 3 mounts) coronary ischemia or CVA (stroke)

Treatment and study plan

Standard colonoscopy

Procedure

Standard Colonoscopy

G-EYE(TM) Colonoscopy

Procedure

G-EYE(TM) Colonoscopy

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

Sponsors and collaborators

Lead sponsor

Smart Medical Systems Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Feb 19, 2014
Registry last updated
Feb 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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