Colonic AdenomaEndorings-2NCT03385434
Evaluation of Endorings-2-assisted Colonoscopy: a New Accessory for Improvement of Adenoma Detection Rate?
A study testing Endorings-2 in people with Colonic Adenoma and Colonic Polyp, run by University Hospital Muenster at 1 site in Germany.
Trial summary
Screening colonoscopy for colorectal cancer is essential to diagnose and remove adenomas, precancerous stages of colorectal cancer. Unfortunately approximately 25 % of all adenomas are missed during the examination. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Colonic Adenoma, Colonic Polyp, Colonic Neoplasms
- What is being tested?
- Endorings-2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 292 participants
- Where
- 1 siteGermany
- Study dates
- 1 Feb 2018to 1 Feb 2022
- 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 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with an indication for a screening colonoscopy.
Who cannot join
- Patients under 18 years, pregnancy
- Patients with prior colectomy or partial colectomy
- Patients with a history of colorectal cancer
- Patients with hereditary polyposis syndromes (FAP, HNPCC)
- Patients with a stricture of the colon
- Patients receiving anticoagulation prohibiting a colonoscopy
- inability to have a patient education
- bad conditions prohibiting a colonoscopy
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Unversity Clinic Muenster
Münster, North Rhine-Westphalia, 48149
Frank Lenze, MD, PhD, 00492518358103, frank.lenze@uni-muenster.de
About this study
Screening colonoscopy for colorectal cancer is essential to diagnose and remove adenomas, precancerous stages of colorectal cancer. Unfortunately approximately 25 % of all adenomas are missed during the examination. Recently a new colonoscopy accessory, the Endorings-2 (EndoAid Ltd., Casearea, Israel), has been designed to improved the detection of adenomas during colonoscopy (adenoma detection rate).
Endorings-2 is a silicone-rubber device that is fitted on the colonoscope and is equipped with circular flexible silicon rings mechanically stretching the colonic folds during withdrawal.
This study aims to evaluate the efficacy of Endorings-2 to improve the adenoma detection rate in a prospective, blinded clinical trial. 292 patients with an indication for a screening colonoscopy shall be included (1:1 randomization in standard colonoscopy versus Endorings-2-assisted colonoscopy).
- Conditions
- Colonic Adenoma, Colonic Polyp, Colonic Neoplasms, Colonoscopy
- Being tested
- Endorings-2
- Keywords
- Colonoscopy; adenoma detection rate; endorings-2; endorings; device-assisted colonoscopy
- Medical subject headings
- Colonic Polyps, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endorings-2Device
Also called Endorings-2 (EndoAid Ltd, Caesarea, Israel)
292 patients with an indication for screening colonoscopy will be included. 146 patients will receive a standard colonoscopy and 146 patients will receive an Endorings-2 assisted colonoscopy (1:1 standard colonoscopy vs Endorings-2-assisted colonoscopy).
| Study group | Role | What they receive |
|---|---|---|
| Endorings-assisted screening colonoscopy | Experimental | 146 patients with an indication for screening endoscopy will receive an Endorings-2-assisted colonoscopy. Receives: Device: Endorings-2 |
| Standard screening colonoscopy | No intervention | 146 patients with an indication for screening endoscopy will receive a standard colonoscopy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the adenoma detection rate during screening colonoscopy
The primary outcome of this study is the adenoma detection rate of the standard colonoscopy in comparison to the Endorings-assisted colonoscopy.
Measured: Intraoperative. Adenomas detected directly during the examination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2017
- Study start1 Feb 2018
- Primary completion30 Aug 2021 (estimated)
- Study completion1 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 292 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03385434
- Sponsor's protocol ID
- 2017-635-f-S
- Acronym
- Endorings-2
- Status last verified
- Jun 2020
- First submitted
- 20 Dec 2017
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Endorings-2-assisted Colonoscopy: a New Accessory for Improvement of Adenoma Detection Rate?
- ClinicalTrials.gov ID
- NCT03385434
- Acronym / sponsor ID
- Endorings-2 / 2017-635-f-S
- Conditions
- Colonic Adenoma, Colonic Polyp, Colonic Neoplasms, Colonoscopy
- Keywords
- Colonoscopy; adenoma detection rate; endorings-2; endorings; device-assisted colonoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 292 participants (estimated)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 30 Aug 2021 (estimated)
- Study completion
- 1 Feb 2022 (estimated)
- First posted
- 28 Dec 2017 (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.
Screening colonoscopy for colorectal cancer is essential to diagnose and remove adenomas, precancerous stages of colorectal cancer. Unfortunately approximately 25 % of all adenomas are missed during the examination. Recently a new colonoscopy accessory, the Endorings-2 (EndoAid Ltd., Casearea, Israel), has been designed to improved the detection of adenomas during colonoscopy (adenoma detection rate).
Endorings-2 is a silicone-rubber device that is fitted on the colonoscope and is equipped with circular flexible silicon rings mechanically stretching the colonic folds during withdrawal.
This study aims to evaluate the efficacy of Endorings-2 to improve the adenoma detection rate in a prospective, blinded clinical trial. 292 patients with an indication for a screening colonoscopy shall be included (1:1 randomization in standard colonoscopy versus Endorings-2-assisted colonoscopy).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endorings-assisted screening colonoscopy | Experimental | Device: Endorings-2146 patients with an indication for screening endoscopy will receive an Endorings-2-assisted colonoscopy. |
| Standard screening colonoscopy | No intervention | –146 patients with an indication for screening endoscopy will receive a standard colonoscopy. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with an indication for a screening colonoscopy.
Key exclusion criteria (8 listed)
- Patients under 18 years, pregnancy
- Patients with prior colectomy or partial colectomy
- Patients with a history of colorectal cancer
- Patients with hereditary polyposis syndromes (FAP, HNPCC)
- Patients with a stricture of the colon
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 |
|---|---|---|
| Endorings-2Also: Endorings-2 (EndoAid Ltd, Caesarea, Israel)292 patients with an indication for screening colonoscopy will be included. 146 patients will receive a standard colonoscopy and 146 patients will receive an Endorings-2 assisted colonoscopy (1:1 standard colonoscopy vs Endorings-2-assisted colonoscopy). | Device | Endorings-assisted screening colonoscopy |
Primary outcome
Evaluation of the adenoma detection rate during screening colonoscopy
Time frame: Intraoperative. Adenomas detected directly during the examination.
The primary outcome of this study is the adenoma detection rate of the standard colonoscopy in comparison to the Endorings-assisted colonoscopy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endorings-2 in people with Colonic Adenoma and Colonic Polyp, run by University Hospital Muenster 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: status not confirmed, as of the sponsor's last update on 16 Jun 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Frank Lenze, MD (+492518357935, frank.lenze@uni-muenster.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the adenoma detection rate during screening colonoscopy (time frame: Intraoperative. Adenomas detected directly during the examination.). 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 16 Jun 2020.