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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Adenoma
• Intervention / Treatment: Procedure: Standard Colonoscopy; Procedure: G-EYE(TM) Colonoscopy

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Frankfurt, Germany, 60318
    • St. Marienkrankenhaus Frankfurt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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:

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Subjects will undergo complete standard colonoscopy, followed by G-EYE(TM) Colonoscopy	Procedure: Standard Colonoscopy; Standard Colonoscopy; Procedure: G-EYE(TM) Colonoscopy; G-EYE(TM) Colonoscopy
Active Comparator: Group B; Subject will undergo G-EYE(TM) colonoscopy followed by standard colonoscopy	Procedure: Standard Colonoscopy; Standard Colonoscopy; Procedure: G-EYE(TM) Colonoscopy; G-EYE(TM) Colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
polyp and adenoma detection, procedure times and safety	24-72 hours post procedure

Collaborators and Investigators

• Sponsor: Smart Medical Systems Ltd.
• Investigators: Principal Investigator: Ralf Kiesslich, Prof.

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: February 10, 2014
• First Submitted That Met QC Criteria: February 16, 2014
• First Posted (Estimate): February 19, 2014

Study Record Updates

• Last Update Posted (Estimate): February 12, 2016
• Last Update Submitted That Met QC Criteria: February 11, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Colorectal Cancer; Adenoma; Standard Colonoscopy; G-EYE(TM) Colonoscopy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Adenoma
• Other Study ID Numbers: G-EYE