Colonic PolypsE-CAPNCT02529007
Endo-cuff Assisted Vs. Standard Colonoscopy for Polyp Detection in Bowel Cancer Screening
A study testing Endo-cuff and Standard colonoscopy in people with Colonic Polyps and Colonic Neoplasms, run by Portsmouth Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
The study evaluates whether the use of a novel endoscopic cap (the endo-cuff) at the tip of a colonoscope improves the numbers of polyps detected during bowel cancer screening colonoscopy. Half the patients will have standard colonoscopy and half will have colonoscopy with the cap attached. Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Colonic Polyps, Colonic Neoplasms
- What is being tested?
- Endo-cuff and Standard colonoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 534 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2014to Sep 2015
- 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 60 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients referred for colonoscopy under the national bowel cancer screening programme
- Able to provide written informed consent
Who cannot join
- History of Inflammatory bowel disease
- History of Hereditary non polyposis colorectal cancer
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Portsmouth Hospitals NHS Trust
Portsmouth, Hampshire, PO6 3LY
About this study
Official title: Endo-cuff Assisted Colonoscopy Versus Standard Colonoscopy for Polyp Detection in Bowel Cancer Screening Patients: A Randomised Controlled Trial. The E-CAP Study
The study evaluates whether the use of a novel endoscopic cap (the endo-cuff) at the tip of a colonoscope improves the numbers of polyps detected during bowel cancer screening colonoscopy. Half the patients will have standard colonoscopy and half will have colonoscopy with the cap attached.
Read the detailed description
Problem statement:
In England, everyone in the age group of 60-69 years is invited to participate in bowel cancer screening. Those who test positive in the initial screening stool test are invited to have a colonoscopy. The purpose of colonoscopy is to detect any obvious cancers, and in the absence of obvious cancers the purpose is to detect and remove all the polyps present in the colon, as polyps have the potential to develop into cancers. However, colonoscopy still misses up to 25% of polyps. Cap assisted colonoscopy improves polyp detection but still misses a significant number of polyps. There is a need for an improved cap design which will help improve polyp detection.
Research question/hypothesis:
Does using an endocuff on a colonoscope improve polyp detection as compared to standard colonoscopy in bowel cancer screening patients?
Study design:
Parallel group, single blinded randomised controlled trial
Study participants:
Patients attending for colonoscopy under the bowel cancer screening programme
Planned sample size: 534
Planned study period: 12 months
Primary objective:
To assess the impact of endocuff assisted colonoscopy on the number of polyps detected per patient
- Conditions
- Colonic Polyps, Colonic Neoplasms
- Being tested
- Endo-cuff, Standard colonoscopy
- Keywords
- Colonoscopy, early cancer detection, cancer screening
- 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.
Endo-cuffDevice
Colonoscopy performed with endo-cuff attached to the colonoscope
Standard colonoscopyOther
Standard colonoscopy without end-cuff
| Study group | Role | What they receive |
|---|---|---|
| Standard | Active comparator | These patients have standard colonoscopy performed Receives: Other: Standard colonoscopy |
| Endocuff | Experimental | These patients have colonoscopy performed with the endo-cuff attached to the end of the colonoscope Receives: Device: Endo-cuff |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of polyps detected per patient
Measured: 1 month (when pathology report available)
Secondary outcomes (9)
Cancer detection rate
Measured: 1 month (when pathology report available)
Polyp detection rate
Measured: 1 month (when pathology report available)
Adenomas per patient
Measured: 1 month (when pathology report available)
Adenoma detection rate
Measured: 1 month (when pathology report available)
Caecal intubation rate
will be recorded at the time of the procedure
Measured: 1 day
Total procedure time - from scope insertion to removal
will be recorded at the time of the procedure
Measured: 1 day
Time taken to reach caecum
will be recorded at the time of the procedure
Measured: 1 day
Time taken to withdraw scope (from caecum to removal of scope)
will be recorded at the time of the procedure
Measured: 1 day
Patient comfort score
will be recorded at the time of the procedure
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2015 (estimated)
- Study startSep 2014
- Primary completionSep 2015
- Study completionSep 2015
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 Colonic 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 534 participants (actual)
Sponsor and investigators
- Lead sponsor
- Portsmouth Hospitals NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Pradeep Bhandari, MBBS, MD, MRCP, Principal investigator, Portsmouth Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02529007
- Sponsor's protocol ID
- PHT/2013/71
- Acronym
- E-CAP
- Status last verified
- Jul 2015
- First submitted
- 17 Jul 2015
- Last updated
- 30 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bhattacharyya R, Chedgy F, Kandiah K, Fogg C, Higgins B, Haysom-Newport B, Gadeke L, Thursby-Pelham F, Ellis R, Goggin P, Longcroft-Wheaton G, Bhandari P. Endocuff-assisted vs. standard colonoscopy in the fecal occult blood test-based UK Bowel Cancer Screening Programme (E-cap study): a randomized trial. Endoscopy. 2017 Nov;49(11):1043-1050. doi: 10.1055/s-0043-111718. Epub 2017 Jun 14.
PubMed 28614895
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endo-cuff Assisted Colonoscopy Versus Standard Colonoscopy for Polyp Detection in Bowel Cancer Screening Patients: A Randomised Controlled Trial. The E-CAP Study
- ClinicalTrials.gov ID
- NCT02529007
- Acronym / sponsor ID
- E-CAP / PHT/2013/71
- Conditions
- Colonic Polyps, Colonic Neoplasms
- Keywords
- Colonoscopy, early cancer detection, cancer screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 534 participants (actual)
- Lead sponsor
- Portsmouth Hospitals NHS TrustOther government
- Study start
- Sep 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 19 Aug 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.
The study evaluates whether the use of a novel endoscopic cap (the endo-cuff) at the tip of a colonoscope improves the numbers of polyps detected during bowel cancer screening colonoscopy. Half the patients will have standard colonoscopy and half will have colonoscopy with the cap attached.
Detailed description
Problem statement:
In England, everyone in the age group of 60-69 years is invited to participate in bowel cancer screening. Those who test positive in the initial screening stool test are invited to have a colonoscopy. The purpose of colonoscopy is to detect any obvious cancers, and in the absence of obvious cancers the purpose is to detect and remove all the polyps present in the colon, as polyps have the potential to develop into cancers. However, colonoscopy still misses up to 25% of polyps. Cap assisted colonoscopy improves polyp detection but still misses a significant number of polyps. There is a need for an improved cap design which will help improve polyp detection.
Research question/hypothesis:
Does using an endocuff on a colonoscope improve polyp detection as compared to standard colonoscopy in bowel cancer screening patients?
Study design:
Parallel group, single blinded randomised controlled trial
Study participants:
Patients attending for colonoscopy under the bowel cancer screening programme
Planned sample size: 534
Planned study period: 12 months
Primary objective:
To assess the impact of endocuff assisted colonoscopy on the number of polyps detected per patient
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard | Active comparator | Other: Standard colonoscopyThese patients have standard colonoscopy performed |
| Endocuff | Experimental | Device: Endo-cuffThese patients have colonoscopy performed with the endo-cuff attached to the end of the colonoscope |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients referred for colonoscopy under the national bowel cancer screening programme
- Able to provide written informed consent
Key exclusion criteria (2 listed)
- History of Inflammatory bowel disease
- History of Hereditary non polyposis colorectal cancer
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 |
|---|---|---|
| Endo-cuffColonoscopy performed with endo-cuff attached to the colonoscope | Device | Endocuff |
| Standard colonoscopyStandard colonoscopy without end-cuff | Other | Standard |
Primary outcome
Number of polyps detected per patient
Time frame: 1 month (when pathology report available)
9 secondary outcomes
Cancer detection rate
Time frame: 1 month (when pathology report available)
Polyp detection rate
Time frame: 1 month (when pathology report available)
Adenomas per patient
Time frame: 1 month (when pathology report available)
Adenoma detection rate
Time frame: 1 month (when pathology report available)
Caecal intubation rate
Time frame: 1 day
Total procedure time - from scope insertion to removal
Time frame: 1 day
Time taken to reach caecum
Time frame: 1 day
Time taken to withdraw scope (from caecum to removal of scope)
Time frame: 1 day
Patient comfort score
Time frame: 1 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 30 May 2016.
- Derived from this study: PubMed 28614895Bhattacharyya R, Chedgy F, Kandiah K, Fogg C, Higgins B, Haysom-Newport B, Gadeke L, Thursby-Pelham F, Ellis R, Goggin P, Longcroft-Wheaton G, Bhandari P. Endocuff-assisted vs. standard colonoscopy in the fecal occult blood test-based UK Bowel Cancer Screening Programme (E-cap study): a randomized trial. Endoscopy. 2017 Nov;49(11):1043-1050. doi: 10.1055/s-0043-111718. Epub 2017 Jun 14.
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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.
Pradeep Bhandari, MBBS, MD, MRCP principal investigator
Portsmouth Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endo-cuff and Standard colonoscopy in people with Colonic Polyps and Colonic Neoplasms, run by Portsmouth Hospitals NHS Trust at 1 site in United Kingdom.
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 2 inclusion and 2 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 30 May 2016. 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 United Kingdom. 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?
Number of polyps detected per patient (time frame: 1 month (when pathology report available)). 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 NCT02529007, 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 30 May 2016; AzTrials last refreshed its copy on 2 Nov 2026.