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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02066064
• Other study ID #: G-EYE
• Status: Completed
• Phase: N/A
• First received: February 10, 2014
• Last updated: February 11, 2016
• Start date: November 2013
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: Smart Medical Systems Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Adenoma
• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Procedure:
• Standard Colonoscopy
Standard Colonoscopy
• G-EYE(TM) Colonoscopy
G-EYE(TM) Colonoscopy

Locations

Country	Name	City	State
Germany	St. Marienkrankenhaus Frankfurt	Frankfurt

Sponsors (1)

Lead Sponsor	Collaborator
Smart Medical Systems Ltd.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	polyp and adenoma detection, procedure times and safety		24-72 hours post procedure	Yes