AdenomaERNCT03469622
EndoRings Colonoscopy for Adenoma Detection
A study testing EndoRings and Standard colonoscopy in people with Adenoma, run by Helios Albert-Schweitzer-Klinik Northeim at 5 sites in Germany.
Trial summary
Adenoma detection rate (ADR) in colon cancer screening is most important for avoiding colon cancer development. Recent studies suggest a benefit of endoscopic devices attached to the distal tip of the colonoscope for improving the ADR. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Adenoma
- What is being tested?
- EndoRings and Standard colonoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 5 sitesGermany
- Study dates
- 27 Mar 2018to 31 Dec 2019
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- indication for colonoscopy (screening, surveillance, diagnostic)
- age ≥ 45 years
- ability to give informed consent
Who cannot join
- pregnancy
- age <45 years
- known colonic strictures
- chronic inflammatory bowel disease
- active inflammation
- s/p colonic resection
- bleeding disorder
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites, 5 recruiting
- Recruiting
Department of Gastroenterology, University Medical Center
Göttingen, Lower Saxony, 37075
Volker Ellenrieder, Professor, +49551390, Volker.Ellenrieder@med.uni-goettingen.de
- Recruiting
HELIOS St. Marienberg Klinik Helmstedt
Helmstedt
Detlev Ameis, Prof.Dr.med., 0049 53 51 14 - 0, detlev.ameis@helios-kliniken.de
Detlev Ameis, Prof.Dr.med.
- Recruiting
Helios Albert-Schweitzer-Hospital, Academic University Teaching Hospital
Northeim, 37154
Tobias Meister, M.D., 00495551971244, tobias.meister@helios-kliniken.de
Tobias Meister, M.D.
- Recruiting
HELIOS Medical Center Siegburg
Siegburg
Michael Schepke, Prof.Dr.med., +49-2241-18-2226, michael.schepke@helios-kliniken.de
Michael Schepke, Prof.Dr.med.
- Recruiting
HELIOS HSK Kliniken
Wiesbaden, Hesse, 65199
Ralf Kiesslich, Prof. Dr., +49611432420, ralf.kiesslich@helios-gesundheit.de
About this study
Official title: EndoRings Versus Standard Colonoscopy for Adenoma Detection
Adenoma detection rate (ADR) in colon cancer screening is most important for avoiding colon cancer development. Recent studies suggest a benefit of endoscopic devices attached to the distal tip of the colonoscope for improving the ADR. This work is the first GERMAN randomized controlled trial comparing standard colonoscopy with EndoRIngs-assisted colonoscopy.
EndoRings is a new FDA approved device that is attached to the distal tip of the colonoscope. Better Polyp detection is suspected by flattening the mucosal folds during withdrawal
- Conditions
- Adenoma
- Being tested
- EndoRings, Standard colonoscopy
- Keywords
- Adenoma, Polyp, EndoRings, Colonoscopy, Endoscopic device, Colon cancer screening
- Medical subject headings
- Adenoma, Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoRingsDevice
EndoRings-assisted colonoscopy
Standard colonoscopyDevice
Standard colonoscopy without any additional devices
| Study group | Role | What they receive |
|---|---|---|
| EndoRings | Active comparator | Colonoscopy is performed with the EndoRings attached Receives: Device: EndoRings |
| Standard Colonoscopy | Active comparator | Standard colonoscopy without any additional devices Receives: Device: Standard colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma detection rate
Measured: during colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study start27 Mar 2018
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helios Albert-Schweitzer-Klinik Northeim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tobias Meister, Prof. Dr., Principal investigator, HELIOS Albert-Schweitzer KlinikRalf Kiesslich, Prof. Dr., Principal investigator, HELIOS HSK Kliniken Wiesbaden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03469622
- Sponsor's protocol ID
- HRC 047721
- Acronym
- ER
- Status last verified
- Feb 2019
- First submitted
- 6 Mar 2018
- Last updated
- 12 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EndoRings Versus Standard Colonoscopy for Adenoma Detection
- ClinicalTrials.gov ID
- NCT03469622
- Acronym / sponsor ID
- ER / HRC 047721
- Conditions
- Adenoma
- Keywords
- Adenoma, Polyp, EndoRings, Colonoscopy, Endoscopic device, Colon cancer screening
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Helios Albert-Schweitzer-Klinik NortheimUniversity, hospital or other
- Study start
- 27 Mar 2018 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 19 Mar 2018 (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.
Adenoma detection rate (ADR) in colon cancer screening is most important for avoiding colon cancer development. Recent studies suggest a benefit of endoscopic devices attached to the distal tip of the colonoscope for improving the ADR. This work is the first GERMAN randomized controlled trial comparing standard colonoscopy with EndoRIngs-assisted colonoscopy.
EndoRings is a new FDA approved device that is attached to the distal tip of the colonoscope. Better Polyp detection is suspected by flattening the mucosal folds during withdrawal
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EndoRings | Active comparator | Device: EndoRingsColonoscopy is performed with the EndoRings attached |
| Standard Colonoscopy | Active comparator | Device: Standard colonoscopyStandard colonoscopy without any additional devices |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- indication for colonoscopy (screening, surveillance, diagnostic)
- age ≥ 45 years
- ability to give informed consent
Key exclusion criteria (7 listed)
- pregnancy
- age <45 years
- known colonic strictures
- chronic inflammatory bowel disease
- active inflammation
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 |
|---|---|---|
| EndoRingsEndoRings-assisted colonoscopy | Device | EndoRings |
| Standard colonoscopyStandard colonoscopy without any additional devices | Device | Standard Colonoscopy |
Primary outcome
Adenoma detection rate
Time frame: during colonoscopy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2019.
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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.
Tobias Meister, Prof. Dr. principal investigator
HELIOS Albert-Schweitzer Klinik
Ralf Kiesslich, Prof. Dr. principal investigator
HELIOS HSK Kliniken Wiesbaden
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EndoRings and Standard colonoscopy in people with Adenoma, run by Helios Albert-Schweitzer-Klinik Northeim at 5 sites 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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 12 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tobias Meister, Prof. Dr. (+495551971244, tobias.meister@helios-gesundheit.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adenoma detection rate (time frame: during colonoscopy). 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 12 Feb 2019.