Colonic NeoplasmsDETECTNCT03254498
Detection in Tandem Endocuff Cap Trial
A study testing Endocuff and cap assisted colonoscopy (CAC) in people with Colonic Neoplasms and Adenomas Serrated, run by London North West Healthcare NHS Trust at 1 site in United Kingdom.
Trial summary
A randomised back to back study comparing cap and Endocuff to detect adenomas during colonoscopy Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Colonic Neoplasms, Adenomas Serrated, Colo-rectal Cancer
- What is being tested?
- Endocuff and cap assisted colonoscopy (CAC)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 154 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2016to May 2017
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years and over
- Referral for surveillance, or diagnostic colonoscopy
- Ability to give informed consent
Who cannot join
- Absolute contraindications to colonoscopy
- Established or suspicion of large bowel obstruction or pseudo-obstruction
- Known colon cancer or polyposis syndromes
- Known colonic strictures
- Known severe diverticular segment (that is likely to impede colonoscope passage)
- Patients with active colitis (ulcerative colitis, Crohn's colitis, diverticulitis, infective colitis)
Show all 9Show fewer
- Patients lacking capacity to give informed consent
- Pregnancy
- Patients who are on clopidogrel, warfarin, or other new generation anticoagulants who have not stopped this for the procedure
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
NorthWest London Hospitals - NOrthwick park hospital
Harrow, Middlesex, HA1 3UJ
About this study
Official title: Is Endocuff Vision Assisted Colonoscopy Superior to Cap Assisted Colonoscopy to Detect Adenomas
A randomised back to back study comparing cap and Endocuff to detect adenomas during colonoscopy
- Being tested
- Endocuff, cap assisted colonoscopy (CAC)
- Keywords
- colonic adenoma, serrated polyps, caecal intubation time, withdrawal time, polyp miss rate
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndocuffDevice
It is a randomised back to back study to compare cap and Endocuff to detect adenoma in colonoscopic examination
cap assisted colonoscopy (CAC)Device
cap assisted colonoscopy (CAC)
| Study group | Role | What they receive |
|---|---|---|
| Endocuff assisted colonoscopy | Active comparator | Participants are randomised to undergo first either with Endocuff or cap assisted colonoscopy during colonoscopy. Receives: Device: Endocuff |
| Cap assisted colonoscopy | Placebo comparator | Participants are randomised to undergo first either with Endocuff or cap assisted colonoscopy during colonoscopy. Receives: Device: cap assisted colonoscopy (CAC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma miss rate
Comparison of adenoma miss rate between cap ( CAC) and Endocuff assisted colonoscopy(E
Measured: 1 day
Secondary outcomes (5)
Mean adenoma per procedure
Difference in mean adenomas detected per procedure (MAP) between EAC and CAC.
Measured: 1 day
Endocuff or cap exchange
Number of times Cap or Endocuff are removed to complete the procedure
Measured: 1 day
Ceacal intubation and withdrawal time
Comparison of caecal intubation and withdrawal time
Measured: 1 day
miss rate of advanced polyps
Comparison of miss rates of advanced adenomas, serrated polyps and proxima polyps between CAC and EAC
Measured: 1 day
Comfort score
Comparison of patient comfort score between CAC and EAC
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 posted18 Aug 2017
- Study startApr 2016
- Primary completionApr 2017
- Study completionMay 2017
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 NeoplasmsStudies 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
- It is a randomised back to back study to compare the performance of cap assisted colonoscopy (CAC) and Endocuff assisted colonoscopy (EAC)
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- London North West Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian P Saunders, MD, Principal investigator, St Mark's Hospital, Northwest London Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03254498
- Sponsor's protocol ID
- RD15/061
- Acronym
- DETECT
- Status last verified
- Aug 2017
- First submitted
- 14 Aug 2017
- Last updated
- 18 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rameshshanker R, Tsiamoulos Z, Wilson A, Rajendran A, Bassett P, Tekkis P, Saunders BP. Endoscopic cuff-assisted colonoscopy versus cap-assisted colonoscopy in adenoma detection: randomized tandem study-DEtection in Tandem Endocuff Cap Trial (DETECT). Gastrointest Endosc. 2020 Apr;91(4):894-904.e1. doi: 10.1016/j.gie.2019.11.046. Epub 2019 Dec 10.
PubMed 31836474
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Endocuff Vision Assisted Colonoscopy Superior to Cap Assisted Colonoscopy to Detect Adenomas
- ClinicalTrials.gov ID
- NCT03254498
- Acronym / sponsor ID
- DETECT / RD15/061
- Keywords
- colonic adenoma, serrated polyps, caecal intubation time, withdrawal time, polyp miss rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- London North West Healthcare NHS TrustUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 18 Aug 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.
A randomised back to back study comparing cap and Endocuff to detect adenomas during colonoscopy
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- It is a randomised back to back study to compare the performance of cap assisted colonoscopy (CAC) and Endocuff assisted colonoscopy (EAC)
| Arm | Type | Receives |
|---|---|---|
| Endocuff assisted colonoscopy | Active comparator | Device: EndocuffParticipants are randomised to undergo first either with Endocuff or cap assisted colonoscopy during colonoscopy. |
| Cap assisted colonoscopy | Placebo comparator | Device: cap assisted colonoscopy (CAC)Participants are randomised to undergo first either with Endocuff or cap assisted colonoscopy during colonoscopy. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years and over
- Referral for surveillance, or diagnostic colonoscopy
- Ability to give informed consent
Key exclusion criteria (9 listed)
- Absolute contraindications to colonoscopy
- Established or suspicion of large bowel obstruction or pseudo-obstruction
- Known colon cancer or polyposis syndromes
- Known colonic strictures
- Known severe diverticular segment (that is likely to impede colonoscope passage)
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 |
|---|---|---|
| EndocuffIt is a randomised back to back study to compare cap and Endocuff to detect adenoma in colonoscopic examination | Device | Endocuff assisted colonoscopy |
| cap assisted colonoscopy (CAC)cap assisted colonoscopy (CAC) | Device | Cap assisted colonoscopy |
Primary outcome
Adenoma miss rate
Time frame: 1 day
Comparison of adenoma miss rate between cap ( CAC) and Endocuff assisted colonoscopy(E
5 secondary outcomes
Mean adenoma per procedure
Time frame: 1 day
Endocuff or cap exchange
Time frame: 1 day
Ceacal intubation and withdrawal time
Time frame: 1 day
miss rate of advanced polyps
Time frame: 1 day
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 18 Aug 2017.
- Derived from this study: PubMed 31836474Rameshshanker R, Tsiamoulos Z, Wilson A, Rajendran A, Bassett P, Tekkis P, Saunders BP. Endoscopic cuff-assisted colonoscopy versus cap-assisted colonoscopy in adenoma detection: randomized tandem study-DEtection in Tandem Endocuff Cap Trial (DETECT). Gastrointest Endosc. 2020 Apr;91(4):894-904.e1. doi: 10.1016/j.gie.2019.11.046. Epub 2019 Dec 10.
- 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.
Brian P Saunders, MD principal investigator
St Mark's Hospital, Northwest London 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 Endocuff and cap assisted colonoscopy (CAC) in people with Colonic Neoplasms and Adenomas Serrated, run by London North West Healthcare 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 3 inclusion and 9 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 18 Aug 2017. 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. Some participants in this study may receive a placebo. 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 miss rate (time frame: 1 day). 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 NCT03254498, 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 18 Aug 2017.