Colonic AdenomaCuff-BercyNCT03344055
Endocuff-assisted Colonoscopy vs Standard Colonoscopy on Adenoma Detection Rate
A study testing Endocuff Vision (ECV) second generation in people with Colonic Adenoma and Colonic Polyp, run by Société Française d'Endoscopie Digestive at 1 site in France.
Trial summary
This is a prospective study comparing endocuff-assisted colonoscopy to standard colonoscopy. The goal of this study is to evaluate the interest of second-generation Endocuff Vision (ECV) to improve Adenoma detection rate and / or Polyp detection rate as the Mean Number of Polyps (average number of polyps) in routine… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Colonic Adenoma, Colonic Polyp, Colonoscopy
- What is being tested?
- Endocuff Vision (ECV) second generation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,059 participants
- Where
- 1 siteFrance
- Study dates
- 15 Nov 2017to 15 Nov 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient scheduled for total colonoscopic exploration, during the period study
- Patient over or equal to 18 years
- ASA 1, ASA 2, ASA 3
- No participation in another clinical study
- Certificate of non opposition signed
Who cannot join
- Patient under 18 years old
- ASA 4, ASA 5
- Pregnant woman
- Patient with coagulation abnormalities preventing polypectomy: prothrombin level <50%, Platelets <50000 / mm3, effective anti-coagulation in progress, clopidogrel in progress.
- Inflammatory bowel disease
- Known colonic stenosis
Show all 9Show fewer
- Diverticulitis less than 6 weeks old
- Patient unable to give consent or protected by law
- Opposition expressed for inclusion in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endocuff-assisted Colonoscopy vs Standard Colonoscopy on Adenoma Detection Rate: A Comparative Prospective Study in Common Practice
This is a prospective study comparing endocuff-assisted colonoscopy to standard colonoscopy. The goal of this study is to evaluate the interest of second-generation Endocuff Vision (ECV) to improve Adenoma detection rate and / or Polyp detection rate as the Mean Number of Polyps (average number of polyps) in routine colonoscopy.
This is a prospective comparative study, on 2000 patients, 1000 in each group (with and without ECV)
Read the detailed description
This is a prospective study comparing endocuff-assisted colonoscopy to standard colonoscopy. The goal of this study is to evaluate the interest of second-generation Endocuff Vision (ECV) to improve Adenoma detection rate and / or Polyp detection rate as the Mean Number of Polyps (average number of polyps) in routine colonoscopy.
Number of patients:
2000 patients, 1000 in each group (with and without ECV). To limit the risk of bias, the investigators will random two teams of 12 endoscopists matched in number, volume of activity and Adenoma Detection Rate (evaluated over a period of the year preceding the study).
Both periods of study will be approximately 3-4 months in length. In order to achieve a perfect balance between the two groups of patients, an inclusion tracking chart will be initiate and will be carefully controlled. Rebalancing will be done for both periods of study to obtain 500 patients per group and per period (= 2000 patients included).
Inclusion of 500 consecutive colonoscopies in each team of investigators, a "colonoscopy with ECV" team, a "colonoscopy without ECV" team then switch and inclusion of 500 new consecutive colonoscopies in each team, ie 2000 colonoscopies in total.
The selection of the team that will begin with ECV (Team A) and the team that will finish with ECV (Team B) will be chosen at random before the start of the study.
A comparison of the two colonoscopy groups with ECV vs without ECV will be made for each team (the investigator will be his own control) and then on the overall population after the end of the trial.
- Conditions
- Colonic Adenoma, Colonic Polyp, Colonoscopy
- Being tested
- Endocuff Vision (ECV) second generation
- Keywords
- Adenoma Detection Rate, Endocuff, Colonoscopy
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endocuff Vision (ECV) second generationDevice
Colonoscopy performed with the use of "Endocuff Vision (ECV) second generation" at the tip of the scope
| Study group | Role | What they receive |
|---|---|---|
| Colonoscopy with Endocuff Vision (ECV) | Active comparator | ECV-assisted colonoscopy ( with the use of Endocuff Vision (ECV) Second generation) Receives: Device: Endocuff Vision (ECV) second generation |
| Standard colonoscopy | No intervention | Standard colonoscopy (without the use of Endocuff Vision (ECV) Second generation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma detection rate (ADR)
rate (%) of colonoscopies with one or more adenoma detected
Measured: during procedure
Secondary outcomes (8)
Polyp detection rate (PDR)
rate (%) of colonoscopies with one or more polyp detected
Measured: during procedure
Advanced neoplasia detection rate (ANDR)
rate (%) of colonoscopies with one or more advanced neoplasia detected
Measured: during procedure
Serrated polyp detection rate (SPDR)
rate (%) of colonoscopies with one or more serrated polyp detected
Measured: during procedure
Morbidity: perforation rate (%)
Perforation rates (%)
Measured: 21 days after procedure
Morbidity: bleeding rate (%)
Bleeding rates (%)
Measured: 21 days after procedure
caecal intubation rate (%)
caecal intubation rate (complete colonoscopy)
Measured: during procedure
Time to reach caecum (sec)
Time to reach caecum from the beginning of the procedure (in seconds)
Measured: during procedure
withdrawal time (sec)
withdrawal time of the scope from the caecum to the end of the procedure (in seconds)
Measured: during procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start15 Nov 2017
- Primary completion15 Nov 2018
- Study completion15 Nov 2018
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 AdenomaStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,059 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société Française d'Endoscopie Digestive
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, KARSENTI, Société Française d'Endoscopie Digestive
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03344055
- Sponsor's protocol ID
- 2017-A00549-44
- Acronym
- Cuff-Bercy
- Status last verified
- Jan 2019
- First submitted
- 12 Nov 2017
- Last updated
- 29 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Karsenti D, Tharsis G, Perrot B, Cattan P, Tordjman G, Venezia F, Zrihen E, Gillot D, Gillet A, Hagege C, Samama J, Etienney I, Lab JP, Guigui B, Zago J, Benkessou B, Burtin P, Cavicchi M. Adenoma detection by Endocuff-assisted versus standard colonoscopy in routine practice: a cluster-randomised crossover trial. Gut. 2020 Dec;69(12):2159-2164. doi: 10.1136/gutjnl-2019-319565. Epub 2020 Mar 24.
PubMed 32209605
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endocuff-assisted Colonoscopy vs Standard Colonoscopy on Adenoma Detection Rate: A Comparative Prospective Study in Common Practice
- ClinicalTrials.gov ID
- NCT03344055
- Acronym / sponsor ID
- Cuff-Bercy / 2017-A00549-44
- Conditions
- Colonic Adenoma, Colonic Polyp, Colonoscopy
- Keywords
- Adenoma Detection Rate, Endocuff, Colonoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,059 participants (actual)
- Lead sponsor
- Société Française d'Endoscopie DigestiveUniversity, hospital or other
- Study start
- 15 Nov 2017 (actual)
- Primary completion
- 15 Nov 2018 (actual)
- Study completion
- 15 Nov 2018 (actual)
- First posted
- 17 Nov 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.
This is a prospective study comparing endocuff-assisted colonoscopy to standard colonoscopy. The goal of this study is to evaluate the interest of second-generation Endocuff Vision (ECV) to improve Adenoma detection rate and / or Polyp detection rate as the Mean Number of Polyps (average number of polyps) in routine colonoscopy.
This is a prospective comparative study, on 2000 patients, 1000 in each group (with and without ECV)
Detailed description
This is a prospective study comparing endocuff-assisted colonoscopy to standard colonoscopy. The goal of this study is to evaluate the interest of second-generation Endocuff Vision (ECV) to improve Adenoma detection rate and / or Polyp detection rate as the Mean Number of Polyps (average number of polyps) in routine colonoscopy.
Number of patients:
2000 patients, 1000 in each group (with and without ECV). To limit the risk of bias, the investigators will random two teams of 12 endoscopists matched in number, volume of activity and Adenoma Detection Rate (evaluated over a period of the year preceding the study).
Both periods of study will be approximately 3-4 months in length. In order to achieve a perfect balance between the two groups of patients, an inclusion tracking chart will be initiate and will be carefully controlled. Rebalancing will be done for both periods of study to obtain 500 patients per group and per period (= 2000 patients included).
Inclusion of 500 consecutive colonoscopies in each team of investigators, a "colonoscopy with ECV" team, a "colonoscopy without ECV" team then switch and inclusion of 500 new consecutive colonoscopies in each team, ie 2000 colonoscopies in total.
The selection of the team that will begin with ECV (Team A) and the team that will finish with ECV (Team B) will be chosen at random before the start of the study.
A comparison of the two colonoscopy groups with ECV vs without ECV will be made for each team (the investigator will be his own control) and then on the overall population after the end of the trial.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colonoscopy with Endocuff Vision (ECV) | Active comparator | Device: Endocuff Vision (ECV) second generationECV-assisted colonoscopy ( with the use of Endocuff Vision (ECV) Second generation) |
| Standard colonoscopy | No intervention | –Standard colonoscopy (without the use of Endocuff Vision (ECV) Second generation) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient scheduled for total colonoscopic exploration, during the period study
- Patient over or equal to 18 years
- ASA 1, ASA 2, ASA 3
- No participation in another clinical study
- Certificate of non opposition signed
Key exclusion criteria (9 listed)
- Patient under 18 years old
- ASA 4, ASA 5
- Pregnant woman
- Patient with coagulation abnormalities preventing polypectomy: prothrombin level <50%, Platelets <50000 / mm3, effective anti-coagulation in progress, clopidogrel in progress.
- Inflammatory bowel disease
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 Vision (ECV) second generationColonoscopy performed with the use of "Endocuff Vision (ECV) second generation" at the tip of the scope | Device | Colonoscopy with Endocuff Vision (ECV) |
Primary outcome
Adenoma detection rate (ADR)
Time frame: during procedure
rate (%) of colonoscopies with one or more adenoma detected
8 secondary outcomes
Polyp detection rate (PDR)
Time frame: during procedure
Advanced neoplasia detection rate (ANDR)
Time frame: during procedure
Serrated polyp detection rate (SPDR)
Time frame: during procedure
Morbidity: perforation rate (%)
Time frame: 21 days after procedure
Morbidity: bleeding rate (%)
Time frame: 21 days after procedure
caecal intubation rate (%)
Time frame: during procedure
Time to reach caecum (sec)
Time frame: during procedure
withdrawal time (sec)
Time frame: during procedure
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 29 Jan 2019.
- Derived from this study: PubMed 32209605Karsenti D, Tharsis G, Perrot B, Cattan P, Tordjman G, Venezia F, Zrihen E, Gillot D, Gillet A, Hagege C, Samama J, Etienney I, Lab JP, Guigui B, Zago J, Benkessou B, Burtin P, Cavicchi M. Adenoma detection by Endocuff-assisted versus standard colonoscopy in routine practice: a cluster-randomised crossover trial. Gut. 2020 Dec;69(12):2159-2164. doi: 10.1136/gutjnl-2019-319565. Epub 2020 Mar 24.
- Individual participant dataSharing planned: No
Related trials for Colonic Adenoma
RecruitingPhase 1
Anti-Mesothelin TNaive/SCM hYP218 (TNhYP218) CAR T Cells in Participants With Mesothelin-Expressing Solid Tumors Including Mesothelioma
Mesothelioma, Neoplasms
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingObservational study
KLF4 Epigenetic Modulation
KLF4 Methylation, Epigenetic
RecruitingPhase 1/2
Lead-212 PSV359 Therapy for Patients With Solid Tumors
Pancreatic Ductal Adenocarcinoma, Gastric Cancer
RecruitingObservational study
Solid Tumor Analysis for HLA Loss of Heterozygosity (LOH) and Apheresis for CAR T- Cell Manufacturing
Solid Tumor, Adult, Colorectal Cancer
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 Vision (ECV) second generation in people with Colonic Adenoma and Colonic Polyp, run by Société Française d'Endoscopie Digestive at 1 site in France.
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 5 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 29 Jan 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 France. 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 detection rate (ADR) (time frame: during procedure). 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 NCT03344055, 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 29 Jan 2019.