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CompletedNCT04708951Updated Oct 22, 2021

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

An interventional study of ENDOCUFF VISION® device and G-EYE® colonoscope in Adenoma and Colorectal Cancer, sponsored by Dr. Horst Schmidt Klinik GmbH. Completed at 3 sites in 2 countries. Per ClinicalTrials.gov, last updated 2021-10-22.

Sponsored by Dr. Horst Schmidt Klinik GmbH · Not applicable, Interventional, and Screening

From the registry’s dates

  • Primary completion was Oct 2021, 5 years ago, and no results have been posted to the registry.
Phase
Not applicable
Study type
Interventional
Enrollment
970
Allocation
Randomized
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Adenoma
  • Colorectal Cancer

Keywords

  • Adenoma
  • Colorectal Cancer
03

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's enrollment of 970 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Dr. Horst Schmidt Klinik GmbH is the lead sponsor of 12 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
970 participants (actual)

Study arms

  • Active comparator
    ECV colonoscopy

    EndoCuff Vision® device (ECV)

    Device: ENDOCUFF VISION® device

  • Experimental
    G-EYE® colonoscopy

    G-EYE® colonoscope (G-EYE)

    Device: G-EYE® colonoscope

Interventions

  • DeviceENDOCUFF 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

  • DeviceG-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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: June 2021

07

Study locations

3 sites
  • IU Health University Hospital
    Indianapolis, Indiana 46202, United States
  • NYU Langone Health
    New York, New York 10016, United States
  • Helios Dr. Horst Schmidt Kliniken Wiesbaden
    Wiesbaden, 65199, Germany
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 22, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04708951
Lead sponsor
Dr. Horst Schmidt Klinik GmbH
Responsible party
Prof. Dr. Ralf Kiesslich (Prof., Dr. Horst Schmidt Klinik GmbH) — Principal investigator
First posted
Jan 14, 2021
Start date
Jan 1, 2021
Primary completion
Oct 1, 2021
Completion
Oct 15, 2021
Last update
Oct 22, 2021

Study contacts

Ralf Kiesslich, Prof.
principal investigator · Helios Dr. Horst Schmidt Kliniken Wiesbaden

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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