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

Smart Medical Systems

Status: Completed

Conditions: Adenoma; Colorectal Cancer

Treatments: Procedure: Standard Colonoscopy; Procedure: G-EYE(TM) Colonoscopy

Study type: Interventional

Funder types: Industry

Identifiers

NCT02066064

G-EYE

Details and patient eligibility

About

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.

Full description

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

Enrollment: 58 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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58 participants in 2 patient groups

Group A

Experimental group

Description:

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

Treatment:

Procedure: G-EYE(TM) Colonoscopy

Procedure: Standard Colonoscopy

Group B

Active Comparator group

Description:

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

Treatment:

Procedure: G-EYE(TM) Colonoscopy

Procedure: Standard Colonoscopy