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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02066064

Enrollment

Registered

2014-02-19

Start date

2013-11-30

Completion date

2015-12-31

Last updated

2016-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenoma, Colorectal Cancer

Keywords

Colorectal Cancer, Adenoma, Standard Colonoscopy, G-EYE(TM) Colonoscopy

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.

Interventions

PROCEDUREStandard Colonoscopy

Standard Colonoscopy

PROCEDUREG-EYE(TM) Colonoscopy

G-EYE(TM) Colonoscopy

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

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

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)

Design outcomes

Primary

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

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026