Colorectal PolypsEC-Cap-SCNCT02331836
Endocuff-assisted Versus Cap-assisted Versus Standard Colonoscopy
A study testing Arc Endocuff (AEC 110, 120, 130, 140), Cap and Standard colonoscope in people with Colorectal Polyps and Colorectal Adenomas, run by Helios Albert-Schweitzer-Klinik Northeim at 6 sites in 2 countries.
Trial summary
Comparison of Endocuff-assisted, Cap-assisted and Standard colonoscopy for assessment of the adenoma detection rate (ADR) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Polyps, Colorectal Adenomas
- What is being tested?
- Arc Endocuff (AEC 110, 120, 130, 140), Cap and Standard colonoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 561 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Feb 2015to 1 Feb 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Colonoscopy independent from indication
- Age ≥ 18
- Patient is able to provide informed consent for the procedure
Who cannot join
- Inflammatory Bowel Disease stenosis
- Pregnant of nursing patient
- Acute diverticulitis
- Active Inflammatory Bowel Disease
- Age ≤ 18
- Coagulation disorder (INR>1.4 , Thrombocytes < 50000/µl)
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Germany5 sites
University Medical Center Göttingen
Göttingen, 37075
HELIOS St. Marienberg Klinik Helmstedt
Helmstedt
University of Muenster
Münster, North Rhine-Westphalia, 48149
HELIOS Albert-Schweitzer-Klinik
Northeim, 37154
HELIOS Medical Center Siegburg
Siegburg
About this study
Official title: Endocuff-assisted Versus Cap-assisted Versus Standard Colonoscopy for Adenoma Detection: A Randomized Controlled European Multicenter Study
Comparison of Endocuff-assisted, Cap-assisted and Standard colonoscopy for assessment of the adenoma detection rate (ADR)
Read the detailed description
The Endocuff is a medical device, approved in 2012 by the American Food and Drug Administration, which was also authorized by the European Agency for the Evaluation of Medicinal Products. The aim of the cuff is to optimize the view of the colonic mucosa. There is also a transparent cap on the market, which is used in colonoscopy for a better evaluation of the mucosa and polyp detection. The goal of this project is to conduct a prospective randomized trial for clarification of the hypotheses, whether the usage of the Endocuff increases the detection rate of adenomas compared to the transparent cap or compared to standard colonoscopy.
- Conditions
- Colorectal Polyps, Colorectal Adenomas
- Being tested
- Arc Endocuff (AEC 110, 120, 130, 140), Cap, Standard colonoscope
- Keywords
- adenoma detection rate, polyp detection rate, withdrawal time, coecal and ileum intubation rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arc Endocuff (AEC 110, 120, 130, 140)Device
CapDevice
Olympus Disposable distal attachment 15mm diameter, 4mm depth
Standard colonoscopeDevice
| Study group | Role | What they receive |
|---|---|---|
| Arc Endocuff (AEC 110, 120, 130, 140) | Active comparator | Endocuff-assisted colonoscopy Colonoscopy with the Endocuff attached at the distal tip of the scope Receives: Device: Arc Endocuff (AEC 110, 120, 130, 140) |
| Cap | Active comparator | Cap-assisted colonoscopy Colonoscopy with the transparent Cap attached at the distal tip of the scope Receives: Device: Cap |
| Standard Colonoscope | Active comparator | Standard colonoscopy without any additional device Receives: Device: Standard colonoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma detection rate
Proportion of patients having at least one adenoma
Measured: 1 year
Polyp detection rate
Proportion of patients having at least one adenoma
Measured: 1 year
Secondary outcomes (8)
Bowel preparation result
Measured: one day
Coecum intubation rate
Measured: one year
Ileum intubation rate
Measured: one year
Coecum intubation time
Measured: one day
withdrawal time
Measured: one day
mucosal laceration
Measured: one day
severe bleeding
Measured: one day
perforation
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2015 (estimated)
- Study startFeb 2015
- Primary completion1 Feb 2019
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal PolypsStudies 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
- 561 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helios Albert-Schweitzer-Klinik Northeim
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tobias Meister, Helios Albert-Schweitzer-Klinik Northeim
- Investigators
- Tobias Meister, Prof. Dr.med., Principal investigator, Helios Albert-Schweitzer-Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02331836
- Sponsor's protocol ID
- EC-CUFF-2015
- Acronym
- EC-Cap-SC
- Status last verified
- Feb 2019
- First submitted
- 2 Jan 2015
- Last updated
- 12 Feb 2019
- Results posted
- No
- Data monitoring committee
- 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
- Endocuff-assisted Versus Cap-assisted Versus Standard Colonoscopy for Adenoma Detection: A Randomized Controlled European Multicenter Study
- ClinicalTrials.gov ID
- NCT02331836
- Acronym / sponsor ID
- EC-Cap-SC / EC-CUFF-2015
- Conditions
- Colorectal Polyps, Colorectal Adenomas
- Keywords
- adenoma detection rate, polyp detection rate, withdrawal time, coecal and ileum intubation rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 561 participants (actual)
- Lead sponsor
- Helios Albert-Schweitzer-Klinik NortheimUniversity, hospital or other
- Study start
- Feb 2015 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 6 Jan 2015 (estimated)
- 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.
Comparison of Endocuff-assisted, Cap-assisted and Standard colonoscopy for assessment of the adenoma detection rate (ADR)
Detailed description
The Endocuff is a medical device, approved in 2012 by the American Food and Drug Administration, which was also authorized by the European Agency for the Evaluation of Medicinal Products. The aim of the cuff is to optimize the view of the colonic mucosa. There is also a transparent cap on the market, which is used in colonoscopy for a better evaluation of the mucosa and polyp detection. The goal of this project is to conduct a prospective randomized trial for clarification of the hypotheses, whether the usage of the Endocuff increases the detection rate of adenomas compared to the transparent cap or compared to standard colonoscopy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arc Endocuff (AEC 110, 120, 130, 140) | Active comparator | Device: Arc Endocuff (AEC 110, 120, 130, 140)Endocuff-assisted colonoscopy Colonoscopy with the Endocuff attached at the distal tip of the scope |
| Cap | Active comparator | Device: CapCap-assisted colonoscopy Colonoscopy with the transparent Cap attached at the distal tip of the scope |
| Standard Colonoscope | Active comparator | Device: Standard colonoscopeStandard colonoscopy without any additional device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Colonoscopy independent from indication
- Age ≥ 18
- Patient is able to provide informed consent for the procedure
Key exclusion criteria (6 listed)
- Inflammatory Bowel Disease stenosis
- Pregnant of nursing patient
- Acute diverticulitis
- Active Inflammatory Bowel Disease
- Age ≤ 18
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 |
|---|---|---|
| Arc Endocuff (AEC 110, 120, 130, 140) | Device | Arc Endocuff (AEC 110, 120, 130, 140) |
| CapOlympus Disposable distal attachment 15mm diameter, 4mm depth | Device | Cap |
| Standard colonoscope | Device | Standard Colonoscope |
Primary outcome
Adenoma detection rate
Time frame: 1 year
Proportion of patients having at least one adenoma
Polyp detection rate
Time frame: 1 year
Proportion of patients having at least one adenoma
8 secondary outcomes
Bowel preparation result
Time frame: one day
Coecum intubation rate
Time frame: one year
Ileum intubation rate
Time frame: one year
Coecum intubation time
Time frame: one day
withdrawal time
Time frame: one day
mucosal laceration
Time frame: one day
severe bleeding
Time frame: one day
perforation
Time frame: one day
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 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.med. principal investigator
Helios Albert-Schweitzer-Hospital
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arc Endocuff (AEC 110, 120, 130, 140), Cap and Standard colonoscope in people with Colorectal Polyps and Colorectal Adenomas, run by Helios Albert-Schweitzer-Klinik Northeim at 6 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 3 inclusion and 6 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 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 6 sites in Germany, Poland. 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?
Adenoma detection rate (time frame: 1 year). 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 12 Feb 2019.