Colorectal AdenomaNCT03219918
Adenoma Detection Rate in Colonoscopy Performed With EndoRings
A study testing EndoRings II Distal Attachment in people with Colorectal Adenoma and Colorectal Neoplasms, run by Zealand University Hospital at 1 site in Denmark.
Trial summary
The study is designed to examine whether colonoscopy using an EndoRings cap has a higher adenoma detection rate than conventional colonoscopy. Secondary end-points is to compare completion rate, completion time, complication rate and detection of malignancies. Read more about this study
- Who is it for?
- Ages 50 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Adenoma, Colorectal Neoplasms
- What is being tested?
- EndoRings II Distal Attachment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteDenmark
- Study dates
- 19 Jun 2017to 7 Jun 2018
- 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 50 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients meeting all the below listed criteria are eligible for inclusion in the trial:
- Age between 50 - 74 years (age range of screening population)
- Positive HemoCult home test from the Danish Colorectal Cancer Screening Programme
- Ability to give informed consent to participation in the trial.
Who cannot join
- Patients meeting one or more of the below listed criteria will be excluded from the trial:
- History of colorectal cancer
- History of Inflammatory Bowel Disease
- Part of other control programme (e.g. HNPCC or adenoma control)
- ASA =/> 4 and/or necessity of general anaesthesia
- Former surgery with removal of a part of the colon on either benign or malignant background
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Zealand University Hospital Køge, Department of Surgery
Køge, 4600
About this study
Official title: Adenoma Detection Rate in Colonoscopy Performed With EndoRings - a Single-centre Prospective Randomised Clinical Trial
The study is designed to examine whether colonoscopy using an EndoRings cap has a higher adenoma detection rate than conventional colonoscopy. Secondary end-points is to compare completion rate, completion time, complication rate and detection of malignancies. Half of the patients will be randomised to colonoscopy using cap and the other half to no cap.
Read the detailed description
Colonoscopy is recognised as the standard method for finding and removing colorectal adenomas, which are precursors of most colorectal cancers. It has been shown that there is a direct correlation between adenoma detection rate and the risk of developing colorectal cancer subsequently. However, patients undergoing colonoscopy are still at risk of developing colorectal cancer, mainly because precursor lesions are missed during the procedure. This may be due to insufficient bowel preparation, difficulties in visualising flat lesions or the location of lesions behind haustral folds.
Improving the ADR can be achieved by different means; better training of endoscopists, improved bowel preparation, optimal sedation and medico technical developments. The technical improvements have mainly been in the optimising of image and improved scope thickness and flexibility, including devices that improve visualisation by increasing the exposed colonic surface . One of these new inventions is the EndoRings II Distal Attachment.
According to the Danish Colorectal Cancer Screening Database, the ADR of standard screening colonoscopy is between 34 and 67 % with a national average of 49 % of patients with detected adenomas. Due to the known adenoma miss rate in standard screening colonoscopies, it is important to increase the ADR on average as well as finding ways to improve ADR for centres with a lower than average ADR.
- Conditions
- Colorectal Adenoma, Colorectal Neoplasms
- Being tested
- EndoRings II Distal Attachment
- Keywords
- Colorectal adenoma, Colonoscopy, Caps, Adenoma detection rate
- Medical subject headings
- Colorectal Neoplasms, Cryopyrin-Associated Periodic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoRings II Distal AttachmentDevice
Colonoscopy cap
| Study group | Role | What they receive |
|---|---|---|
| With EndoRings | Active comparator | Colonoscopy is performed with the use of the cap-device EndoRings II Distal Attachment to be attached to the tip of the colonoscope Receives: Device: EndoRings II Distal Attachment |
| NO EndoRings | No intervention | Colonoscopy is performed conventionally without any caps |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma detection rate
Number of colorectal adenomas/neoplasms/carcinomas found in colonoscopy
Measured: maximum 60 minutes
Secondary outcomes (3)
Completion time
Overall colonoscopy duration
Measured: maximum 60 minutes
Completion rate
Colonoscopy completion (intubation to coecum)
Measured: maximum 60 minutes
Malignancy detection
Number of colorectal malignancies found in colonoscopy
Measured: maximum 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2017
- Study start19 Jun 2017
- Primary completion7 Jun 2018
- Study completion7 Jun 2018
Why it stopped: Practically difficult to inroll the number of patients anticipated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal AdenomaStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe sponsor's other registered studies.
- 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
- Model description
- The study is a single-centre prospective randomised clinical trial. Patients are included if they meet the specified inclusion criteria and accept to take part in the study after proper oral and written information (see patient information below). Specimens i.e. removed adenomas and biopsies of suspected malignancies are analysed by pathologists according to standard procedure. The pathologist will not know the nature of specimen collection (colonoscopy with or without EndoRings). The specimens are not saved for any other study related activities.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Line E Line, MD, Principal investigator, Zealand University Hospital KøgeIsmayil Gögenur, Prof, DMSc, Study director, Zealand University Hospital Køge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03219918
- Sponsor's protocol ID
- ZUH-KØGE-KIR1
- Status last verified
- Apr 2019
- First submitted
- 13 Jun 2017
- Last updated
- 11 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- 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 11 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adenoma Detection Rate in Colonoscopy Performed With EndoRings - a Single-centre Prospective Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT03219918
- Acronym / sponsor ID
- ZUH-KØGE-KIR1
- Conditions
- Colorectal Adenoma, Colorectal Neoplasms
- Keywords
- Colorectal adenoma, Colonoscopy, Caps, Adenoma detection rate
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Practically difficult to inroll the number of patients anticipated
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- 19 Jun 2017 (actual)
- Primary completion
- 7 Jun 2018 (actual)
- Study completion
- 7 Jun 2018 (actual)
- First posted
- 18 Jul 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.
The study is designed to examine whether colonoscopy using an EndoRings cap has a higher adenoma detection rate than conventional colonoscopy. Secondary end-points is to compare completion rate, completion time, complication rate and detection of malignancies. Half of the patients will be randomised to colonoscopy using cap and the other half to no cap.
Detailed description
Colonoscopy is recognised as the standard method for finding and removing colorectal adenomas, which are precursors of most colorectal cancers. It has been shown that there is a direct correlation between adenoma detection rate and the risk of developing colorectal cancer subsequently. However, patients undergoing colonoscopy are still at risk of developing colorectal cancer, mainly because precursor lesions are missed during the procedure. This may be due to insufficient bowel preparation, difficulties in visualising flat lesions or the location of lesions behind haustral folds.
Improving the ADR can be achieved by different means; better training of endoscopists, improved bowel preparation, optimal sedation and medico technical developments. The technical improvements have mainly been in the optimising of image and improved scope thickness and flexibility, including devices that improve visualisation by increasing the exposed colonic surface . One of these new inventions is the EndoRings II Distal Attachment.
According to the Danish Colorectal Cancer Screening Database, the ADR of standard screening colonoscopy is between 34 and 67 % with a national average of 49 % of patients with detected adenomas. Due to the known adenoma miss rate in standard screening colonoscopies, it is important to increase the ADR on average as well as finding ways to improve ADR for centres with a lower than average ADR.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The study is a single-centre prospective randomised clinical trial. Patients are included if they meet the specified inclusion criteria and accept to take part in the study after proper oral and written information (see patient information below). Specimens i.e. removed adenomas and biopsies of suspected malignancies are analysed by pathologists according to standard procedure. The pathologist will not know the nature of specimen collection (colonoscopy with or without EndoRings). The specimens are not saved for any other study related activities.
| Arm | Type | Receives |
|---|---|---|
| With EndoRings | Active comparator | Device: EndoRings II Distal AttachmentColonoscopy is performed with the use of the cap-device EndoRings II Distal Attachment to be attached to the tip of the colonoscope |
| NO EndoRings | No intervention | –Colonoscopy is performed conventionally without any caps |
Who may qualify
- Ages
- 50 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 50 - 74 years (age range of screening population)
- Positive HemoCult home test from the Danish Colorectal Cancer Screening Programme
- Ability to give informed consent to participation in the trial.
Key exclusion criteria (6 listed)
- Patients meeting one or more of the below listed criteria will be excluded from the trial:
- History of colorectal cancer
- History of Inflammatory Bowel Disease
- Part of other control programme (e.g. HNPCC or adenoma control)
- ASA =/> 4 and/or necessity of general anaesthesia
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 II Distal AttachmentColonoscopy cap | Device | With EndoRings |
Primary outcome
Adenoma detection rate
Time frame: maximum 60 minutes
Number of colorectal adenomas/neoplasms/carcinomas found in colonoscopy
3 secondary outcomes
Completion time
Time frame: maximum 60 minutes
Completion rate
Time frame: maximum 60 minutes
Malignancy detection
Time frame: maximum 60 minutes
Results and safety
The study was stopped early (reason given: Practically difficult to inroll the number of patients anticipated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2019.
- 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.
Line E Line, MD principal investigator
Zealand University Hospital Køge
Ismayil Gögenur, Prof, DMSc study director
Zealand University Hospital Køge
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 II Distal Attachment in people with Colorectal Adenoma and Colorectal Neoplasms, run by Zealand University Hospital at 1 site in Denmark.
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 4 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: stopped early, as of the sponsor's last update on 11 Apr 2019. 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 Denmark. 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 was stopped early (reason given: Practically difficult to inroll the number of patients anticipated). Results are not available in the source record.
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: maximum 60 minutes). 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 11 Apr 2019; AzTrials last refreshed its copy on 6 Nov 2026.