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

Primary Purpose

Adenoma, Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
ENDOCUFF VISION® device
G-EYE® colonoscope
Sponsored by
Dr. Horst Schmidt Klinik GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Adenoma focused on measuring Adenoma, Colorectal Cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • IU Health University Hospital
  • NYU Langone Health
  • Helios Dr. Horst Schmidt Kliniken Wiesbaden

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

ECV colonoscopy

G-EYE® colonoscopy

Arm Description

EndoCuff Vision® device (ECV)

G-EYE® colonoscope (G-EYE)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 11, 2021
Last Updated
October 21, 2021
Sponsor
Dr. Horst Schmidt Klinik GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT04708951
Brief Title
Comparison of Adenoma Detection Rate With ENDOCUFF VISION® vs. G-EYE®
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®)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
October 1, 2021 (Actual)
Study Completion Date
October 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dr. Horst Schmidt Klinik GmbH

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenoma, Colorectal Cancer
Keywords
Adenoma, Colorectal Cancer

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Subjects will be randomized to one of two groups - ECV colonoscopy or G-EYE® colonoscopy
Masking
None (Open Label)
Allocation
Randomized
Enrollment
970 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ECV colonoscopy
Arm Type
Active Comparator
Arm Description
EndoCuff Vision® device (ECV)
Arm Title
G-EYE® colonoscopy
Arm Type
Experimental
Arm Description
G-EYE® colonoscope (G-EYE)
Intervention Type
Device
Intervention Name(s)
ENDOCUFF VISION® device
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
G-EYE® colonoscope
Intervention Description
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
Primary Outcome Measure Information:
Title
Comparison between adenoma detection rate of G-EYE® colonoscopy and EndoCuff Vision®
Description
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.
Time Frame
June 2021

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Screening and surveillance population for Adenoma and CRC. The patient must understand and sign a written informed consent for the procedure. Exclusion Criteria: Subjects with inflammatory bowel disease; Subjects with a personal history of hereditary polyposis syndrome; Subjects with suspected chronic stricture potentially precluding complete colonoscopy; Subjects with diverticulitis or toxic megacolon; Subjects with prior colonic surgery (exclusion appendectomy) Subjects with a history of radiation therapy to abdomen or pelvis; Pregnant or lactating female subjects; Subjects who are currently enrolled in another clinical investigation. Subjects with current oral or parenteral use of anticoagulants, not considered eligible by the investigator. Subjects with recent (within the last 3 mounts) coronary ischemia or CVA (stroke) Any patient condition deemed too risky for the study by the investigator
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ralf Kiesslich, Prof.
Organizational Affiliation
Helios Dr. Horst Schmidt Kliniken Wiesbaden
Official's Role
Principal Investigator
Facility Information:
Facility Name
IU Health University Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Helios Dr. Horst Schmidt Kliniken Wiesbaden
City
Wiesbaden
ZIP/Postal Code
65199
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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