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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04708951
Other study ID # ENDOCUFF vs. G-EYE
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2021
Est. completion date October 15, 2021

Study information

Verified date October 2021
Source Dr. Horst Schmidt Klinik GmbH
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study is intended to compare the detection rate obtained by performing G-EYE® high definition colonoscopy vs. the detection rate obtained by performing ECV high definition colonoscopy.


Description:

This is a multicenter, two-arm, randomized, open-label study intended to compare the detection rate obtained by performing G-EYE® high definition colonoscopy vs. the detection rate obtained by performing ECV high definition colonoscopy.


Recruitment information / eligibility

Status Completed
Enrollment 970
Est. completion date October 15, 2021
Est. primary completion date October 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: 1. Screening and surveillance population for Adenoma and CRC. 2. The patient must understand and sign a written informed consent for the procedure. Exclusion Criteria: 1. Subjects with inflammatory bowel disease; 2. Subjects with a personal history of hereditary polyposis syndrome; 3. Subjects with suspected chronic stricture potentially precluding complete colonoscopy; 4. Subjects with diverticulitis or toxic megacolon; 5. Subjects with prior colonic surgery (exclusion appendectomy) 6. Subjects with a history of radiation therapy to abdomen or pelvis; 7. Pregnant or lactating female subjects; 8. Subjects who are currently enrolled in another clinical investigation. 9. Subjects with current oral or parenteral use of anticoagulants, not considered eligible by the investigator. 10. Subjects with recent (within the last 3 mounts) coronary ischemia or CVA (stroke) 11. Any patient condition deemed too risky for the study by the investigator

Study Design


Related Conditions & MeSH terms


Intervention

Device:
ENDOCUFF VISION® device
ENDOCUFF VISION® is a disposable cap placed on the tip of a standard colonoscope, intended to flatten colonic folds and assist in controlling the colonoscope's field of view and tip positioning
G-EYE® colonoscope
The G-EYE® balloon is a reusable (reprocessable) balloon permanently installed on the distal tip of a standard colonoscope, and is also intended to assist in flattening colonic folds and control the colonoscope's field of view and tip positioning

Locations

Country Name City State
Germany Helios Dr. Horst Schmidt Kliniken Wiesbaden Wiesbaden
United States IU Health University Hospital Indianapolis Indiana
United States NYU Langone Health New York New York

Sponsors (1)

Lead Sponsor Collaborator
Dr. Horst Schmidt Klinik GmbH

Countries where clinical trial is conducted

United States,  Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Comparison between adenoma detection rate of G-EYE® colonoscopy and EndoCuff Vision® G-EYE® colonoscopy adenoma detection rate will be compared to the adenoma detection rate of EndoCuff Vision® colonoscopy. The primary performance measure is the adenoma detection rate (ADR), which is defined as the percentage of subjects with at least one adenoma found, in each of the study groups. June 2021
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