Colorectal NeoplasiaErings™NCT02785783
Endorings™ Assisted Colonoscopy Versus Standard Colonoscopy for Polyp Detection
A study testing Standard colonoscopy and EndoRings™ in people with Colorectal Neoplasia and Intestinal Neoplasms, run by Portsmouth Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
This study evaluates the impact of Endorings™ assisted colonoscopy on the number of polyps detected per patient compared to standard colonoscopy without use of EndoRings™. Half of the participants will receive EndoRings™ assisted colonoscopy, while the other half will receive standard colonoscopy. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Colorectal Neoplasia, Intestinal Neoplasms, Digestive Neoplasms
- What is being tested?
- Standard colonoscopy and EndoRings™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 563 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 May 2016to 7 Aug 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic patients referred for colonoscopy age ≥ 55.
- Asymptomatic patients age ≥55 undergoing screening or surveillance for polyps and cancers.
Who cannot join
- History of Inflammatory bowel disease
- History of Hereditary non polyposis colorectal cancer (HNPCC)
- Familial adenomatous polyposis syndrome (FAP)
- Hyperplastic polyposis syndrome
- Known colonic stricture
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Portsmouth University Hospital
Portsmouth, Hampshire, PO63LY
About this study
Official title: Endorings™ Assisted Colonoscopy Versus Standard Colonoscopy for Polyp Detection in Symptomatic and Asymptomatic Patients: A Randomised Controlled Trial
This study evaluates the impact of Endorings™ assisted colonoscopy on the number of polyps detected per patient compared to standard colonoscopy without use of EndoRings™. Half of the participants will receive EndoRings™ assisted colonoscopy, while the other half will receive standard colonoscopy.
Read the detailed description
Colonoscopy is the gold standard for detection of colorectal neoplasia (polyps and cancers) but it is well known that colonoscopy is associated with a neoplasia miss rate of up to 25%.
One such method of reducing the neoplasia miss rate is cap assisted colonoscopy, where a cap is placed at the distal end of the colonoscope.The theory behind how the cap aids mucosal visualisation is that it depresses and flattens colonic folds, thereby improving visualisation on the proximal sides of folds.
Investigators aim to evaluate the impact of one such cap assisted device: EndoRings™ on polyp detection rates. EndoRings™ has been shown to improve polyp detection rate by 51% compared to 29% for standard colonoscopy in a recent tandem endoscopy study. EndoRings™ has received FDA approval.
- Conditions
- Colorectal Neoplasia, Intestinal Neoplasms, Digestive Neoplasms, Digestive System Disease, Intestinal Disease, Gastrointestinal Disease
- Being tested
- Standard colonoscopy, EndoRings™
- Keywords
- EndoRings™
- Medical subject headings
- Intestinal Neoplasms, Digestive System Diseases, Intestinal Diseases, Gastrointestinal Diseases, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard colonoscopyDevice
Also called Current standard of care colonoscopy
EndoRings™Device
Colonoscopy performed with an EndoRings™ device at the tip of a standard colonoscope
| Study group | Role | What they receive |
|---|---|---|
| Standard colonoscopy | Active comparator | A standard colonoscope will be used to complete the procedure Receives: Device: Standard colonoscopy |
| EndoRings™ | Active comparator | An EndoRings™ device will be placed at the distal end of a standard colonoscope Receives: Device: EndoRings™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of polyps per patient
To assess the impact of the Endorings™ cap on the number of polyps detected per patient as compared to standard colonoscopy.
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2016 (estimated)
- Study start13 May 2016
- Primary completion7 Aug 2018
- Study completion7 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal NeoplasiaStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 563 participants (actual)
Sponsor and investigators
- Lead sponsor
- Portsmouth Hospitals NHS Trust
- Sponsor type
- Other government
- Collaborators
- University of Portsmouth
- Responsible party
- Sponsor
- Investigators
- Pradeep Bhandari, MD, Principal investigator, Portsmouth University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02785783
- Sponsor's protocol ID
- PHT/2015/101
- Acronym
- Erings™
- Status last verified
- Jan 2019
- First submitted
- 25 May 2016
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
van Rijn JC, Reitsma JB, Stoker J, Bossuyt PM, van Deventer SJ, Dekker E. Polyp miss rate determined by tandem colonoscopy: a systematic review. Am J Gastroenterol. 2006 Feb;101(2):343-50. doi: 10.1111/j.1572-0241.2006.00390.x.
PubMed 16454841Dik VK, Gralnek IM, Segol O, Suissa A, Belderbos TD, Moons LM, Segev M, Domanov S, Rex DK, Siersema PD. Multicenter, randomized, tandem evaluation of EndoRings colonoscopy--results of the CLEVER study. Endoscopy. 2015 Dec;47(12):1151-8. doi: 10.1055/s-0034-1392421. Epub 2015 Jul 28.
PubMed 26220283
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endorings™ Assisted Colonoscopy Versus Standard Colonoscopy for Polyp Detection in Symptomatic and Asymptomatic Patients: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02785783
- Acronym / sponsor ID
- Erings™ / PHT/2015/101
- Conditions
- Colorectal Neoplasia, Intestinal Neoplasms, Digestive Neoplasms, Digestive System Disease, Intestinal Disease, Gastrointestinal Disease
- Keywords
- EndoRings™
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 563 participants (actual)
- Lead sponsor
- Portsmouth Hospitals NHS TrustOther government
- Collaborators
- University of Portsmouth
- Study start
- 13 May 2016 (actual)
- Primary completion
- 7 Aug 2018 (actual)
- Study completion
- 7 Aug 2018 (actual)
- First posted
- 30 May 2016 (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.
This study evaluates the impact of Endorings™ assisted colonoscopy on the number of polyps detected per patient compared to standard colonoscopy without use of EndoRings™. Half of the participants will receive EndoRings™ assisted colonoscopy, while the other half will receive standard colonoscopy.
Detailed description
Colonoscopy is the gold standard for detection of colorectal neoplasia (polyps and cancers) but it is well known that colonoscopy is associated with a neoplasia miss rate of up to 25%.
One such method of reducing the neoplasia miss rate is cap assisted colonoscopy, where a cap is placed at the distal end of the colonoscope.The theory behind how the cap aids mucosal visualisation is that it depresses and flattens colonic folds, thereby improving visualisation on the proximal sides of folds.
Investigators aim to evaluate the impact of one such cap assisted device: EndoRings™ on polyp detection rates. EndoRings™ has been shown to improve polyp detection rate by 51% compared to 29% for standard colonoscopy in a recent tandem endoscopy study. EndoRings™ has received FDA approval.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard colonoscopy | Active comparator | Device: Standard colonoscopyA standard colonoscope will be used to complete the procedure |
| EndoRings™ | Active comparator | Device: EndoRings™An EndoRings™ device will be placed at the distal end of a standard colonoscope |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Symptomatic patients referred for colonoscopy age ≥ 55.
- Asymptomatic patients age ≥55 undergoing screening or surveillance for polyps and cancers.
Key exclusion criteria (5 listed)
- History of Inflammatory bowel disease
- History of Hereditary non polyposis colorectal cancer (HNPCC)
- Familial adenomatous polyposis syndrome (FAP)
- Hyperplastic polyposis syndrome
- Known colonic stricture
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 |
|---|---|---|
| Standard colonoscopyAlso: Current standard of care colonoscopy | Device | Standard colonoscopy |
| EndoRings™Colonoscopy performed with an EndoRings™ device at the tip of a standard colonoscope | Device | EndoRings™ |
Primary outcome
Number of polyps per patient
Time frame: 14 months
To assess the impact of the Endorings™ cap on the number of polyps detected per patient as compared to standard colonoscopy.
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 4 Feb 2019.
- Background: PubMed 16454841van Rijn JC, Reitsma JB, Stoker J, Bossuyt PM, van Deventer SJ, Dekker E. Polyp miss rate determined by tandem colonoscopy: a systematic review. Am J Gastroenterol. 2006 Feb;101(2):343-50. doi: 10.1111/j.1572-0241.2006.00390.x.
- Background: PubMed 26220283Dik VK, Gralnek IM, Segol O, Suissa A, Belderbos TD, Moons LM, Segev M, Domanov S, Rex DK, Siersema PD. Multicenter, randomized, tandem evaluation of EndoRings colonoscopy--results of the CLEVER study. Endoscopy. 2015 Dec;47(12):1151-8. doi: 10.1055/s-0034-1392421. Epub 2015 Jul 28.
- 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.
Pradeep Bhandari, MD principal investigator
Portsmouth University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard colonoscopy and EndoRings™ in people with Colorectal Neoplasia and Intestinal 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 5 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 4 Feb 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 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 per patient (time frame: 14 months). 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 NCT02785783, which also lists 2 linked publications.
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 4 Feb 2019.