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

Not Applicable

Completed

• Conditions: Colorectal Cancer; Adenoma
• Interventions: Procedure: Standard Colonoscopy; Procedure: G-EYE(TM) Colonoscopy

• Registration Number: NCT02066064
• Lead Sponsor: Smart Medical Systems Ltd.

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.

Detailed Description

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

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2014-02-10
• Study First Submitted QC: 2014-02-16
• Study First Posted: 2014-02-19
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-11
• Last Update Posted: 2016-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group B	Standard Colonoscopy	Subject will undergo G-EYE(TM) colonoscopy followed by standard colonoscopy
Group A	Standard Colonoscopy	Subjects will undergo complete standard colonoscopy, followed by G-EYE(TM) Colonoscopy
Group A	G-EYE(TM) Colonoscopy	Subjects will undergo complete standard colonoscopy, followed by G-EYE(TM) Colonoscopy
Group B	G-EYE(TM) Colonoscopy	Subject will undergo G-EYE(TM) colonoscopy followed by standard colonoscopy

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
polyp and adenoma detection, procedure times and safety	24-72 hours post procedure

Trial Locations

Locations (1)

St. Marienkrankenhaus Frankfurt; 🇩🇪 Frankfurt, Germany