Adenoma ColonNCT04651062
Detection of Adenomas in Screening Colonoscopy
A study testing endocuff and no endocuff in people with Adenoma Colon, run by Herning Hospital at 1 site in Denmark.
Trial summary
The Endocuff study aims to show an increase of the number of detected adenomas in screening colonoscopies when a endocuff vision (Arc Medical Design Ldt Leeds England) is used. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Adenoma Colon
- What is being tested?
- endocuff and no endocuff
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,178 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Oct 2017to 1 Apr 2020
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- all Citizens participating in the national bowel screening program
Who cannot join
- persons who are disabled and who do not understand the Danish language
- persons treated with Marcoumar, Marevan, Eliquis, Pradaxa e.g. and who are not eligible to polyp resection
- persons who due to diseases of the eyes or Heart are not allowed to receive Buscopan.
- persons with active colitis/diverticulitis, colon stenosis e.g. due to cancer, where a complete colonoscopy is not possible to achieve
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Detection of Adenomas in Screening Colonoscopy - Endocuff Study
The Endocuff study aims to show an increase of the number of detected adenomas in screening colonoscopies when a endocuff vision (Arc Medical Design Ldt Leeds England) is used.
Read the detailed description
Endocuff is a relatively new device which is intended to be attached to the end of the colonoscope. Several minor studies have shown that the use of Endocuff probably increases the number of detected polyps in colonoscopy. Endocuff is made of soft plastic and has been designed to give an optimal view of the entire colon. It gently averts and flattens folds in order to see small polyps "hiding" in the space behind colonic folds.
The purpose of this study is to investigate into the effect of the Endocuff in screening colonoscopy compared with screening colonoscopy performed without Endocuff. The device has been used during several years yet an effect on the number of polyps detected during screenings colonoscopy has not been shown. This studies main hypothesis is that the use of Endocuff in screenings colonoscopy will increase the adenoma detection rate in these patients, with a potential to reduce interval cancer.
This study is a randomized controlled trial with 900 patients.
- Conditions
- Adenoma Colon
- Being tested
- endocuff, no endocuff
- Keywords
- adenoma detection rate, screening colonoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endocuffDevice
Endocuff is a relatively new device which is intended to be attached to the end of the colonoscope.
no endocuffProcedure or surgery
colonoscopy is performed without endocuff.
| Study group | Role | What they receive |
|---|---|---|
| endocuff | Experimental | all patients having performed a screeningscolonoscopy and being randomized to colonoscopy with the use of endocuff Receives: Device: endocuff |
| no cuff | Active comparator | all patients participating in a screeningscolonoscopy being randomized to colonoscopy without the use of endocuff Receives: Procedure: no endocuff |
What is being measured
The primary outcome is the main question the study is designed to answer.
adenoma
number of adenomas found during colonoscopy
Measured: 2 weeks
Secondary outcomes (5)
cecal intubation rate
is the cecum reached during the colonoscopy
Measured: up to 2 hours
cecal intubation time
number of minutes from start procedure to cecum reached
Measured: up to 2 hours
withdrawal time
number of minutes from cecum reached to end of the procedure, only if no polyps are found
Measured: up to 60 minutes
adenoma size
size of adenomas detected
Measured: up to 4 weeks
adenoma site
where in the bowel the adenoma was detected
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start1 Oct 2017
- Primary completion1 Dec 2018
- Study completion1 Apr 2020
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 Adenoma ColonStudies 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
- Model description
- this is a randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 1,178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herning Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Jaensch, Herning Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04651062
- Sponsor's protocol ID
- 1-16-02-828-17
- Status last verified
- Nov 2020
- First submitted
- 1 Mar 2018
- Last updated
- 3 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jaensch C, Jepsen MH, Christiansen DH, Madsen AH, Madsen MR. Adenoma and serrated lesion detection with distal attachment in screening colonoscopy: a randomized controlled trial. Surg Endosc. 2022 Sep;36(9):1-9. doi: 10.1007/s00464-022-09049-5. Epub 2022 Feb 9.
PubMed 35141776
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Adenomas in Screening Colonoscopy - Endocuff Study
- ClinicalTrials.gov ID
- NCT04651062
- Acronym / sponsor ID
- 1-16-02-828-17
- Conditions
- Adenoma Colon
- Keywords
- adenoma detection rate, screening colonoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,178 participants (actual)
- Lead sponsor
- Herning HospitalUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 3 Dec 2020 (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 Endocuff study aims to show an increase of the number of detected adenomas in screening colonoscopies when a endocuff vision (Arc Medical Design Ldt Leeds England) is used.
Detailed description
Endocuff is a relatively new device which is intended to be attached to the end of the colonoscope. Several minor studies have shown that the use of Endocuff probably increases the number of detected polyps in colonoscopy. Endocuff is made of soft plastic and has been designed to give an optimal view of the entire colon. It gently averts and flattens folds in order to see small polyps "hiding" in the space behind colonic folds.
The purpose of this study is to investigate into the effect of the Endocuff in screening colonoscopy compared with screening colonoscopy performed without Endocuff. The device has been used during several years yet an effect on the number of polyps detected during screenings colonoscopy has not been shown. This studies main hypothesis is that the use of Endocuff in screenings colonoscopy will increase the adenoma detection rate in these patients, with a potential to reduce interval cancer.
This study is a randomized controlled trial with 900 patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- this is a randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| endocuff | Experimental | Device: endocuffall patients having performed a screeningscolonoscopy and being randomized to colonoscopy with the use of endocuff |
| no cuff | Active comparator | Procedure: no endocuffall patients participating in a screeningscolonoscopy being randomized to colonoscopy without the use of endocuff |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all Citizens participating in the national bowel screening program
Key exclusion criteria (4 listed)
- persons who are disabled and who do not understand the Danish language
- persons treated with Marcoumar, Marevan, Eliquis, Pradaxa e.g. and who are not eligible to polyp resection
- persons who due to diseases of the eyes or Heart are not allowed to receive Buscopan.
- persons with active colitis/diverticulitis, colon stenosis e.g. due to cancer, where a complete colonoscopy is not possible to achieve
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 |
|---|---|---|
| endocuffEndocuff is a relatively new device which is intended to be attached to the end of the colonoscope. | Device | endocuff |
| no endocuffcolonoscopy is performed without endocuff. | Procedure or surgery | no cuff |
Primary outcome
adenoma
Time frame: 2 weeks
number of adenomas found during colonoscopy
5 secondary outcomes
cecal intubation rate
Time frame: up to 2 hours
cecal intubation time
Time frame: up to 2 hours
withdrawal time
Time frame: up to 60 minutes
adenoma size
Time frame: up to 4 weeks
adenoma site
Time frame: up to 4 weeks
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 3 Dec 2020.
- Derived from this study: PubMed 35141776Jaensch C, Jepsen MH, Christiansen DH, Madsen AH, Madsen MR. Adenoma and serrated lesion detection with distal attachment in screening colonoscopy: a randomized controlled trial. Surg Endosc. 2022 Sep;36(9):1-9. doi: 10.1007/s00464-022-09049-5. Epub 2022 Feb 9.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endocuff and no endocuff in people with Adenoma Colon, run by Herning 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 1 inclusion and 4 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 3 Dec 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 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 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 (time frame: 2 weeks). 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 NCT04651062, 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 3 Dec 2020.