Colorectal NeoplasmsSinoEVADRNCT03839277
Adenoma Detection Rate Using Endocuff Vision in China
A study testing Endocuff Vision in people with Colorectal Neoplasms and Colonic Polyp, run by Changhai Hospital at 5 sites in China.
Trial summary
The primary aim of this study is to explore the usefulness of Endocuff Vision in colonoscopy on adenoma detection rate (ADR). Other aims include to explore the data below when Endocuff Vision is used. Read more about this study
- Who is it for?
- Ages 45 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Neoplasms, Colonic Polyp, Adenoma
- What is being tested?
- Endocuff Vision
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 5 sitesChina
- Study dates
- 12 Jun 2019to 1 Dec 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 45 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients referred for screening, surveillance, or diagnostic colonoscopy
- All patients must be able to give informed consent
Who cannot join
- Patients with any absolute contraindications to colonoscopy
- Patients with established or suspicion of large bowel obstruction or pseudo-obstruction
- Patients with known colon cancer or polyposis syndromes
- Patients with known colonic strictures
- Patients with known severe diverticular segments (that is likely to impede colonoscope passage)
- Patients with active colitis (ulcerative colitis, Crohn's colitis, diverticulitis, infective colitis)
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- 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.
- Patients who are attending for a therapeutic procedure or assessment of a known lesion
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Sixth affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510655
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, 200032
Changhai Hospital
Shanghai, Shanghai Municipality, 200433
Tianjin Nankai Hospital
Tianjin, Tianjin Municipality, 300100
Tianjin People's Hospital
Tianjin, Tianjin Municipality, 300121
About this study
The primary aim of this study is
- to explore the usefulness of Endocuff Vision in colonoscopy on adenoma detection rate (ADR).
Other aims include to explore the data below when Endocuff Vision is used.
Mean adenomas detected per procedure, MAP Proximal Adenoma detection rate, pADR Polyp detection rate, PDR Proximal polyp detection rate, pPDR Mean polyps detected per procedure, MPP Withdrawal time, WT Cecal intubation rate, CIR Cecal intubation time, CIT
Read the detailed description
Colorectal cancer is common in China. Most colorectal cancers happen when an adenoma becomes cancerous. Doctors use colonoscopy to look inside the colon and rectum and find adenomas and remove them. Removing adenomas is known to reduce the chances of a person developing colorectal cancers. The ability of colonoscopists finding adenomas varies, and there is a lot of researches into how to improve "adenoma detection rates".
A new device, called the Endocuff Vision has been shown to improve the rate of polyp detection at colonoscopy, and to make polyp removal easier. Previous studies have shown that there is a significant improvement in detection of adenomas when an Endocuff Vision is used (with the rate of detection of adenomas rising from 49% to 66%). Colonoscopists who have used the Endocuff Vision before also feel that polyp removal is easier when it is on the colonoscope. This study will randomise patients coming for colonoscopy to have their procedure performed as usual or as an Endocuff Vision-assisted colonoscopy. The investigators will record polyp and adenoma detection rates, duration of procedure, participant comfort levels, and complications. All patients referred for colonoscopy will be invited in 5 centres, recruiting a total of 1200 participants.
- Conditions
- Colorectal Neoplasms, Colonic Polyp, Adenoma
- Being tested
- Endocuff Vision
- Keywords
- adenoma detection rate
- Medical subject headings
- Colorectal Neoplasms, Colonic Polyps, Adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endocuff VisionDevice
Endocuff Vision is attached to the tip of colonoscope before intubation.
| Study group | Role | What they receive |
|---|---|---|
| Endocuff Vision-assisted Colonoscopy | Active comparator | Participants in this arm undergo Endocuff Vision-assisted colonoscopy Receives: Device: Endocuff Vision |
| Standard Colonoscopy | No intervention | Participants in this arm undergo standard colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma detection rate, ADR
ADR refer to the rate of adenoma detection, calculated as the proportion of subjects with at least one adenoma.
Measured: At the end of the procedure, up to 1 hour.
Secondary outcomes (1)
Polyp detection rate, PDR
PDR refer to the rate of polyp detection, calculated as the proportion of subjects with at least one polyp.
Measured: At the end of the procedure, up to 1 hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start12 Jun 2019
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Why it stopped: One investigator is out-of-service due to carrying out another task.
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 Colorectal 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
- Endocuff Vision is a new device made of soft plastic material with a unique dynamic shape. It is manufactured by ARC Medical Design Limited and Diagmed in the United Kingdom. It has European Conformity in United Kingdom. The core is made of polypropylene and the 'finger like' projections are made of a thermoplastic elastomer. It comes in four colour coded sizes (purple, blue, green and orange) to fit a range of paediatric and adult colonoscopes. Endocuff Vision is the more updated version of device that has only one proximal row of more rounded finger-like projections. It is mounted at the tip of the colonoscope and held on by friction (pull-off force is a minimum of 10 Newtons).
- Masking
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sixth Affiliated Hospital, Sun Yat-sen University, Shanghai Zhongshan Hospital, Tianjin People's Hospital, Tianjin Nankai Hospital
- Responsible party
- Principal investigator, En-Da Yu, Changhai Hospital
- Investigators
- En-Da YU, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03839277
- Sponsor's protocol ID
- SINOCOLO2019A
- Acronym
- SinoEVADR
- Status last verified
- Sep 2020
- First submitted
- 11 Feb 2019
- Last updated
- 28 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ngu WS, Bevan R, Tsiamoulos ZP, Bassett P, Hoare Z, Rutter MD, Clifford G, Totton N, Lee TJ, Ramadas A, Silcock JG, Painter J, Neilson LJ, Saunders BP, Rees CJ. Improved adenoma detection with Endocuff Vision: the ADENOMA randomised controlled trial. Gut. 2019 Feb;68(2):280-288. doi: 10.1136/gutjnl-2017-314889. Epub 2018 Jan 23.
PubMed 29363535
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adenoma Detection Rate Using Endocuff Vision in China
- ClinicalTrials.gov ID
- NCT03839277
- Acronym / sponsor ID
- SinoEVADR / SINOCOLO2019A
- Conditions
- Colorectal Neoplasms, Colonic Polyp, Adenoma
- Keywords
- adenoma detection rate
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: One investigator is out-of-service due to carrying out another task.
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Collaborators
- Sixth Affiliated Hospital, Sun Yat-sen University, Shanghai Zhongshan Hospital, Tianjin People's Hospital, Tianjin Nankai Hospital
- Study start
- 12 Jun 2019 (actual)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 15 Feb 2019 (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 primary aim of this study is
- to explore the usefulness of Endocuff Vision in colonoscopy on adenoma detection rate (ADR).
Other aims include to explore the data below when Endocuff Vision is used.
Mean adenomas detected per procedure, MAP Proximal Adenoma detection rate, pADR Polyp detection rate, PDR Proximal polyp detection rate, pPDR Mean polyps detected per procedure, MPP Withdrawal time, WT Cecal intubation rate, CIR Cecal intubation time, CIT
Detailed description
Colorectal cancer is common in China. Most colorectal cancers happen when an adenoma becomes cancerous. Doctors use colonoscopy to look inside the colon and rectum and find adenomas and remove them. Removing adenomas is known to reduce the chances of a person developing colorectal cancers. The ability of colonoscopists finding adenomas varies, and there is a lot of researches into how to improve "adenoma detection rates".
A new device, called the Endocuff Vision has been shown to improve the rate of polyp detection at colonoscopy, and to make polyp removal easier. Previous studies have shown that there is a significant improvement in detection of adenomas when an Endocuff Vision is used (with the rate of detection of adenomas rising from 49% to 66%). Colonoscopists who have used the Endocuff Vision before also feel that polyp removal is easier when it is on the colonoscope. This study will randomise patients coming for colonoscopy to have their procedure performed as usual or as an Endocuff Vision-assisted colonoscopy. The investigators will record polyp and adenoma detection rates, duration of procedure, participant comfort levels, and complications. All patients referred for colonoscopy will be invited in 5 centres, recruiting a total of 1200 participants.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Endocuff Vision is a new device made of soft plastic material with a unique dynamic shape. It is manufactured by ARC Medical Design Limited and Diagmed in the United Kingdom. It has European Conformity in United Kingdom. The core is made of polypropylene and the 'finger like' projections are made of a thermoplastic elastomer. It comes in four colour coded sizes (purple, blue, green and orange) to fit a range of paediatric and adult colonoscopes. Endocuff Vision is the more updated version of device that has only one proximal row of more rounded finger-like projections. It is mounted at the tip of the colonoscope and held on by friction (pull-off force is a minimum of 10 Newtons).
| Arm | Type | Receives |
|---|---|---|
| Endocuff Vision-assisted Colonoscopy | Active comparator | Device: Endocuff VisionParticipants in this arm undergo Endocuff Vision-assisted colonoscopy |
| Standard Colonoscopy | No intervention | –Participants in this arm undergo standard colonoscopy |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients referred for screening, surveillance, or diagnostic colonoscopy
- All patients must be able to give informed consent
Key exclusion criteria (10 listed)
- Patients with any absolute contraindications to colonoscopy
- Patients with established or suspicion of large bowel obstruction or pseudo-obstruction
- Patients with known colon cancer or polyposis syndromes
- Patients with known colonic strictures
- Patients with known severe diverticular segments (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 |
|---|---|---|
| Endocuff VisionEndocuff Vision is attached to the tip of colonoscope before intubation. | Device | Endocuff Vision-assisted Colonoscopy |
Primary outcome
Adenoma detection rate, ADR
Time frame: At the end of the procedure, up to 1 hour.
ADR refer to the rate of adenoma detection, calculated as the proportion of subjects with at least one adenoma.
1 secondary outcome
Polyp detection rate, PDR
Time frame: At the end of the procedure, up to 1 hour.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2020.
- Background: PubMed 29363535Ngu WS, Bevan R, Tsiamoulos ZP, Bassett P, Hoare Z, Rutter MD, Clifford G, Totton N, Lee TJ, Ramadas A, Silcock JG, Painter J, Neilson LJ, Saunders BP, Rees CJ. Improved adenoma detection with Endocuff Vision: the ADENOMA randomised controlled trial. Gut. 2019 Feb;68(2):280-288. doi: 10.1136/gutjnl-2017-314889. Epub 2018 Jan 23.
- PubMed linkLink provided by the sponsor.
- 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.
En-Da YU principal investigator
Changhai Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endocuff Vision in people with Colorectal Neoplasms and Colonic Polyp, run by Changhai Hospital at 5 sites in China.
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 10 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: paused, as of the sponsor's last update on 28 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. 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?
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, ADR (time frame: At the end of the procedure, up to 1 hour.). 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 NCT03839277, 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 28 Sep 2020.