PolypNCT02034929
EndoCuff-assisted Versus Standard Colonoscopy for Adenoma Detection
A study testing EndoCuff-assisted colonoscopy and Standard colonoscopy in people with Polyp and Adenoma, run by Helios Albert-Schweitzer-Klinik Northeim at 4 sites in Germany.
Trial summary
The EndoCuff is novel flexible cuff that can be attached to the distal tip of the colonoscope and helps to flatten large mucosal folds during withdrawal. The study hypothesis is that the use of the Endocuff (EC) increases the adenoma detection rate during colonoscopy. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- EndoCuff-assisted colonoscopy and Standard colonoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 4 sitesGermany
- Study dates
- Jan 2014to Jul 2014
- 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
- indication for colonoscopy (screening, surveillance, diagnostic) ager ≥ 18 years ability to give informed consent
Who cannot join
- pregnancy
- age<18 years
- known colonic strictures
- chronic inflammatory bowel disease
- active inflammation
- s/p colonic resection
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
University Medical Center Göttingen
Göttingen, 37575
HELIOS St. Marienberg Hospital Helmstedt
Helmstedt, 38350
Helios Albert-Schweitzer-Hospital, Academic University Teaching Hospital
Northeim, 37154
HELIOS Medical Center Siegburg, Department of Gastroenterology
Siegburg, 53721
About this study
Official title: A Randomized Controlled Study to Compare EndoCuff-assisted With Standard Colonoscopy for the Detection of Adenomas
The EndoCuff is novel flexible cuff that can be attached to the distal tip of the colonoscope and helps to flatten large mucosal folds during withdrawal.
The study hypothesis is that the use of the Endocuff (EC) increases the adenoma detection rate during colonoscopy.
The study purpose is to compare EC-assisted colonoscopy with standard colonoscopy for polyp detection.
- Being tested
- EndoCuff-assisted colonoscopy, Standard colonoscopy
- Keywords
- colon cancer, adenoma, colon polyps
- Medical subject headings
- Polyps, Adenoma, Neoplasms, Colonic Neoplasms, Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoCuff-assisted colonoscopyDevice
EC-assisted colonoscopy
Standard colonoscopyDevice
Standard colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| Endocuff-assisted colonoscopy | Active comparator | Endocuff-assisted colonoscopy Receives: Device: EndoCuff-assisted colonoscopy |
| Standard colonoscopy | Active comparator | Standard Colonoscopy Receives: Device: Standard colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
adenoma detection rate
completion of colonoscopy is defined as the time point at which the colonoscope has been pulled out of the body.
Measured: 25 minutes
Secondary outcomes (8)
polyp detection rate
Measured: 1 Week
number of LGIN and HGIN adenomas detected
LGIN= low grade intraepithelial neoplasia HGIN= high grade intraepithelial neoplasia
Measured: one week
polyp distribution
Measured: 25 minutes
procedure time
Measured: 25 Minutes
withdrawal time
without intervention time due to polypectomy
Measured: 10 Minutes
ileum intubation rate
Measured: 10 minutes
total colonoscopy rate
Measured: 25 minutes
adverse events
perforation, cuff loss, lacerations, major bleedings, drop of sO2 during colonoscopy
Measured: 25 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PolypStudies 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
- 500 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, M.D., Principal investigator, Helios Albert-Schweitzer-Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02034929
- Sponsor's protocol ID
- HRS ID 003053
- Status last verified
- Mar 2018
- First submitted
- 6 Jan 2014
- Last updated
- 7 Mar 2018
- Results posted
- No
Publications
Floer M, Biecker E, Fitzlaff R, Roming H, Ameis D, Heinecke A, Kunsch S, Ellenrieder V, Strobel P, Schepke M, Meister T. Higher adenoma detection rates with endocuff-assisted colonoscopy - a randomized controlled multicenter trial. PLoS One. 2014 Dec 3;9(12):e114267. doi: 10.1371/journal.pone.0114267. eCollection 2014.
PubMed 25470133
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study to Compare EndoCuff-assisted With Standard Colonoscopy for the Detection of Adenomas
- ClinicalTrials.gov ID
- NCT02034929
- Acronym / sponsor ID
- HRS ID 003053
- Keywords
- colon cancer, adenoma, colon polyps
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Helios Albert-Schweitzer-Klinik NortheimUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 14 Jan 2014 (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.
The EndoCuff is novel flexible cuff that can be attached to the distal tip of the colonoscope and helps to flatten large mucosal folds during withdrawal.
The study hypothesis is that the use of the Endocuff (EC) increases the adenoma detection rate during colonoscopy.
The study purpose is to compare EC-assisted colonoscopy with standard colonoscopy for polyp detection.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endocuff-assisted colonoscopy | Active comparator | Device: EndoCuff-assisted colonoscopyEndocuff-assisted colonoscopy |
| Standard colonoscopy | Active comparator | Device: Standard colonoscopyStandard Colonoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- indication for colonoscopy (screening, surveillance, diagnostic) ager ≥ 18 years ability to give informed consent
Key exclusion criteria (6 listed)
- pregnancy
- age<18 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 |
|---|---|---|
| EndoCuff-assisted colonoscopyEC-assisted colonoscopy | Device | Endocuff-assisted colonoscopy |
| Standard colonoscopyStandard colonoscopy | Device | Standard colonoscopy |
Primary outcome
adenoma detection rate
Time frame: 25 minutes
completion of colonoscopy is defined as the time point at which the colonoscope has been pulled out of the body.
8 secondary outcomes
polyp detection rate
Time frame: 1 Week
number of LGIN and HGIN adenomas detected
Time frame: one week
polyp distribution
Time frame: 25 minutes
procedure time
Time frame: 25 Minutes
withdrawal time
Time frame: 10 Minutes
ileum intubation rate
Time frame: 10 minutes
total colonoscopy rate
Time frame: 25 minutes
adverse events
Time frame: 25 minutes
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 7 Mar 2018.
- Derived from this study: PubMed 25470133Floer M, Biecker E, Fitzlaff R, Roming H, Ameis D, Heinecke A, Kunsch S, Ellenrieder V, Strobel P, Schepke M, Meister T. Higher adenoma detection rates with endocuff-assisted colonoscopy - a randomized controlled multicenter trial. PLoS One. 2014 Dec 3;9(12):e114267. doi: 10.1371/journal.pone.0114267. eCollection 2014.
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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, M.D. principal investigator
Helios Albert-Schweitzer-Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EndoCuff-assisted colonoscopy and Standard colonoscopy in people with Polyp and Adenoma, run by Helios Albert-Schweitzer-Klinik Northeim at 4 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 1 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 7 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
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: 25 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02034929, which also lists 1 linked publication.
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 7 Mar 2018.