AdenomaNCT04708951
Comparison of Adenoma Detection Rate With ENDOCUFF VISION® vs. G-EYE®
A study testing ENDOCUFF VISION® device and G-EYE® colonoscope in people with Adenoma and Colorectal Cancer, run by Dr. Horst Schmidt Klinik GmbH at 3 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Adenoma, Colorectal Cancer
- What is being tested?
- ENDOCUFF VISION® device and G-EYE® colonoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 970 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Jan 2021to 15 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Screening and surveillance population for Adenoma and CRC.
- The patient must understand and sign a written informed consent for the procedure.
Who cannot join
- 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;
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- 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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
IU Health University Hospital
Indianapolis, Indiana, 46202
NYU Langone Health
New York, New York, 10016
About this study
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®)
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.
- Conditions
- Adenoma, Colorectal Cancer
- Being tested
- ENDOCUFF VISION® device, G-EYE® colonoscope
- Keywords
- Adenoma, Colorectal Cancer
- Medical subject headings
- Adenoma, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENDOCUFF VISION® deviceDevice
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® colonoscopeDevice
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
| Study group | Role | What they receive |
|---|---|---|
| ECV colonoscopy | Active comparator | EndoCuff Vision® device (ECV) Receives: Device: ENDOCUFF VISION® device |
| G-EYE® colonoscopy | Experimental | G-EYE® colonoscope (G-EYE) Receives: Device: G-EYE® colonoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: June 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start1 Jan 2021
- Primary completion1 Oct 2021
- Study completion15 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdenomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomized to one of two groups - ECV colonoscopy or G-EYE® colonoscopy
- Masking
- None (open label)
- Enrolment
- 970 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Horst Schmidt Klinik GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Prof. Dr. Ralf Kiesslich, Dr. Horst Schmidt Klinik GmbH
- Investigators
- Ralf Kiesslich, Prof., Principal investigator, Helios Dr. Horst Schmidt Kliniken Wiesbaden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04708951
- Sponsor's protocol ID
- ENDOCUFF vs. G-EYE
- Status last verified
- Oct 2021
- First submitted
- 11 Jan 2021
- Last updated
- 22 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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®)
- ClinicalTrials.gov ID
- NCT04708951
- Acronym / sponsor ID
- ENDOCUFF vs. G-EYE
- Conditions
- Adenoma, Colorectal Cancer
- Keywords
- Adenoma, Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 970 participants (actual)
- Lead sponsor
- Dr. Horst Schmidt Klinik GmbHIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 15 Oct 2021 (actual)
- First posted
- 14 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects will be randomized to one of two groups - ECV colonoscopy or G-EYE® colonoscopy
| Arm | Type | Receives |
|---|---|---|
| ECV colonoscopy | Active comparator | Device: ENDOCUFF VISION® deviceEndoCuff Vision® device (ECV) |
| G-EYE® colonoscopy | Experimental | Device: G-EYE® colonoscopeG-EYE® colonoscope (G-EYE) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Screening and surveillance population for Adenoma and CRC.
- The patient must understand and sign a written informed consent for the procedure.
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ENDOCUFF VISION® deviceENDOCUFF 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 | Device | ECV colonoscopy |
| G-EYE® colonoscopeThe 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 | Device | G-EYE® colonoscopy |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ralf Kiesslich, Prof. principal investigator
Helios Dr. Horst Schmidt Kliniken Wiesbaden
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ENDOCUFF VISION® device and G-EYE® colonoscope in people with Adenoma and Colorectal Cancer, run by Dr. Horst Schmidt Klinik GmbH at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison between adenoma detection rate of G-EYE® colonoscopy and EndoCuff Vision® (time frame: June 2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2021.