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Comparison of Adenoma Detection Rate With ENDOCUFF VISION® vs. G-EYE®

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04708951
Recruitment Status : Completed
First Posted : January 14, 2021
Last Update Posted : October 22, 2021
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Ralf Kiesslich, Dr. Horst Schmidt Klinik GmbH

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Adenoma Colorectal Cancer Device: ENDOCUFF VISION® device Device: G-EYE® colonoscope Not Applicable

Detailed 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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 970 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Subjects will be randomized to one of two groups - ECV colonoscopy or G-EYE® colonoscopy
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: A Prospective Randomized Comparison of Colonoscopy Adenoma Detection Rate With a Disposable Cap (ENDOCUFF VISION®) (Endocuff) Versus a Permanently Mounted Balloon (G-EYE®)
Actual Study Start Date : January 1, 2021
Actual Primary Completion Date : October 1, 2021
Actual Study Completion Date : October 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: ECV colonoscopy
EndoCuff Vision® device (ECV)
 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
Experimental: G-EYE® colonoscopy
G-EYE® colonoscope (G-EYE)
 Device: 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


Outcome Measures
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Primary Outcome Measures :
  1. Comparison between adenoma detection rate of G-EYE® colonoscopy and EndoCuff Vision® [ Time Frame: June 2021 ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04708951


Locations
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United States, Indiana
IU Health University Hospital
Indianapolis, Indiana, United States, 46202
United States, New York
NYU Langone Health
New York, New York, United States, 10016
Germany
Helios Dr. Horst Schmidt Kliniken Wiesbaden
Wiesbaden, Germany, 65199
Sponsors and Collaborators
Dr. Horst Schmidt Klinik GmbH
Investigators
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Principal Investigator: Ralf Kiesslich, Prof. Helios Dr. Horst Schmidt Kliniken Wiesbaden
More Information
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Responsible Party: Prof. Dr. Ralf Kiesslich, Prof., Dr. Horst Schmidt Klinik GmbH
ClinicalTrials.gov Identifier: NCT04708951    
Other Study ID Numbers: ENDOCUFF vs. G-EYE
First Posted: January 14, 2021    Key Record Dates
Last Update Posted: October 22, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Prof. Dr. Ralf Kiesslich, Dr. Horst Schmidt Klinik GmbH:
Adenoma
Colorectal Cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Adenoma
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type