AdenomaNCT04767971
Clinical Value of G-EYE Colonoscopy in Daily Practice for Adenoma Detection and Time for Polyp Removal
An observational study of Adenoma and Colo-rectal Cancer, run by Dr. Horst Schmidt Klinik GmbH at 1 site in Germany.
Trial summary
Colonoscopy parameters will be compared before the introduction of the G-EYE endoscope and after the introduction of the G-EYE endoscope Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Adenoma, Colo-rectal Cancer
- What is being tested?
- Standard Colonoscopy and G-EYE Colonoscopy
- Type of treatment
- Medical device
- How many people
- 2,795 participants
- Where
- 1 siteGermany
- Study dates
- 1 Mar 2020to 1 May 2021
- Phase
- Observational
- 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
Study population: Screening and surveillance colonoscopy patients
Who may be able to join
- Indication for screening or surveillance colonoscopy based on the German guideline for colon cancer screening
Who cannot join
- Emergency procedure
- Patients with known inflammatory bowel diseases
- Patients with hereditary cancer syndromes
- Patients with acute colonic inflammation (e.g. diverticulitis, ischemic colitis)
- Patients after radiation of the abdomen or pelvis
- Patients with colonic surgery (except appendectomy)
- Patients with incomplete colonoscopy
- Patients with insufficient bowel preparation
Trial locations and contacts
1 site in 1 country.
About this study
Colonoscopy parameters will be compared before the introduction of the G-EYE endoscope and after the introduction of the G-EYE endoscope
Read the detailed description
Colonoscopy parameters such as demographics, findings and procedural times will be compared before the introduction of the G-EYE endoscope and after the introduction of the G-EYE endoscope
- Conditions
- Adenoma, Colo-rectal Cancer
- Being tested
- Standard Colonoscopy, G-EYE Colonoscopy
- Keywords
- Adenoma, Colorectal Cancer
- Medical subject headings
- Adenoma, Colonic Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard ColonoscopyDevice
Colonoscopy with a standard colonoscope
G-EYE ColonoscopyDevice
Colonoscopy with a G-EYE Colonoscope
| Study group | Role | What they receive |
|---|---|---|
| Standard Colonoscopy | Colonoscopy with a standard colonoscope Receives: Device: Standard Colonoscopy | |
| G-EYE® Colonoscopy | Colonoscopy with a G-EYE Colonoscopy Receives: Device: G-EYE Colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection rate - measured by adenoma detection rate (% subjects having at least 1 adenoma)
G-EYE® colonoscopy adenoma detection rate compared to adenoma detection rate of standard colonoscopy
Measured: February 2021
Effectiveness of intervention - measured by polyp removal time (mm:ss)
G-EYE® colonoscopy polyp removal time compared to polyp removal time of standard colonoscopy
Measured: February 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start1 Mar 2020
- Primary completion1 Apr 2021
- Study completion1 May 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 2,795 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
- NCT04767971
- Sponsor's protocol ID
- G-EYE
- Status last verified
- Oct 2021
- First submitted
- 18 Feb 2021
- Last updated
- 22 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- 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
- Clinical Value of G-EYE Colonoscopy in Daily Practice for Adenoma Detection and Time for Polyp Removal
- ClinicalTrials.gov ID
- NCT04767971
- Acronym / sponsor ID
- G-EYE
- Conditions
- Adenoma, Colo-rectal Cancer
- Keywords
- Adenoma, Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,795 participants (actual)
- Lead sponsor
- Dr. Horst Schmidt Klinik GmbHIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 23 Feb 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.
Colonoscopy parameters will be compared before the introduction of the G-EYE endoscope and after the introduction of the G-EYE endoscope
Detailed description
Colonoscopy parameters such as demographics, findings and procedural times will be compared before the introduction of the G-EYE endoscope and after the introduction of the G-EYE endoscope
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Colonoscopy | – | Device: Standard ColonoscopyColonoscopy with a standard colonoscope |
| G-EYE® Colonoscopy | – | Device: G-EYE ColonoscopyColonoscopy with a G-EYE Colonoscopy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Screening and surveillance colonoscopy patients
Key inclusion criteria (1 listed)
- Indication for screening or surveillance colonoscopy based on the German guideline for colon cancer screening
Key exclusion criteria (8 listed)
- Emergency procedure
- Patients with known inflammatory bowel diseases
- Patients with hereditary cancer syndromes
- Patients with acute colonic inflammation (e.g. diverticulitis, ischemic colitis)
- Patients after radiation of the abdomen or pelvis
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 |
|---|---|---|
| Standard ColonoscopyColonoscopy with a standard colonoscope | Device | Standard Colonoscopy |
| G-EYE ColonoscopyColonoscopy with a G-EYE Colonoscope | Device | G-EYE® Colonoscopy |
Primary outcome
Detection rate - measured by adenoma detection rate (% subjects having at least 1 adenoma)
Time frame: February 2021
G-EYE® colonoscopy adenoma detection rate compared to adenoma detection rate of standard colonoscopy
Effectiveness of intervention - measured by polyp removal time (mm:ss)
Time frame: February 2021
G-EYE® colonoscopy polyp removal time compared to polyp removal time of standard colonoscopy
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adenoma and Colo-rectal Cancer, run by Dr. Horst Schmidt Klinik GmbH at 1 site in Germany.
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 1 inclusion and 8 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 1 site in 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?
Detection rate - measured by adenoma detection rate (% subjects having at least 1 adenoma) (time frame: February 2021). The study lists 2 primary outcomes in all. 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.