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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2015-12-31

Brief Summary

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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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Detailed Description

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

Conditions

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Colorectal Cancer Adenoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Group A

Subjects will undergo complete standard colonoscopy, followed by G-EYE(TM) Colonoscopy

Group Type EXPERIMENTAL

Standard Colonoscopy

Intervention Type PROCEDURE

Standard Colonoscopy

G-EYE(TM) Colonoscopy

Intervention Type PROCEDURE

G-EYE(TM) Colonoscopy

Group B

Subject will undergo G-EYE(TM) colonoscopy followed by standard colonoscopy

Group Type ACTIVE_COMPARATOR

Standard Colonoscopy

Intervention Type PROCEDURE

Standard Colonoscopy

G-EYE(TM) Colonoscopy

Intervention Type PROCEDURE

G-EYE(TM) Colonoscopy

Interventions

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Standard Colonoscopy

Intervention Type PROCEDURE

G-EYE(TM) Colonoscopy

Intervention Type PROCEDURE

Eligibility Criteria

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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)

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes