G-Eye Advanced Colonoscopy For Increased Polyp Detection Rate-randomized Tandem Study With Different Endoscopist
Not Applicable
Completed
- Conditions
- Colorectal CancerAdenoma
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 58
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- 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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms enhance adenoma detection using G-EYE™ technology in colonoscopy?
How does G-EYE™ colonoscopy compare to standard HD colonoscopy in detecting advanced colorectal neoplasia?
Are there specific biomarkers associated with increased polyp detection rates in NCT02066064?
What adverse events were reported in G-EYE™ colonoscopy trials and how were they managed?
What are the implications of G-EYE™ technology for future colon cancer screening guidelines and endoscopic imaging advancements?
Trial Locations
- Locations (1)
St. Marienkrankenhaus Frankfurt
🇩🇪Frankfurt, Germany
St. Marienkrankenhaus Frankfurt🇩🇪Frankfurt, Germany