Colonic PolypCUFF-TROCADERONCT03758872
CUFF-assisted Colonoscopy vs Standard Colonoscopy
An observational study of Colonic Polyp and Colonoscopy, run by Clinique du Trocadéro at 1 site in France.
Trial summary
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 in routine colonoscopy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonic Polyp, Colonoscopy
- What is being tested?
- cuff assisted colonoscopy(with cuff use of endocuff vision second generation)
- How many people
- 1,034 participants
- Where
- 1 siteFrance
- Study dates
- 25 Oct 2018to 26 Sep 2019
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient of all participating physicians for total colonoscopic exploration over the study periods
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
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- 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: USE OF ENDOCUFF SECOND GENERATION IN THE COLIC POLYPS DETECTION: HISTORIC COHORTE PROSPECTIVE COMPARATIVE
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 in routine colonoscopy.
This is a prospective comparative cohort, on 1034 patients, 517 patients with ECV in prospective group and 517 without ECV in retrospective group
- Conditions
- Colonic Polyp, Colonoscopy
- Being tested
- cuff assisted colonoscopy(with cuff use of endocuff vision second generation)
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cuff assisted colonoscopy(with cuff use of endocuff vision second generation)Diagnostic test
Also called colonoscopy with polypectomy or mucosectomy, standard colonoscopy ( without use of endocuff vision)
this is a cohort prospective comparative, a group without cuff in 2017, 517 patient included in the retrospective phase, and in 2018, 517 patient will be included in the prospective phase with CUFF for detecting polyps
| Study group | Role | What they receive |
|---|---|---|
| historical comparaison whithout cuff | 517 patients included in 2017 without CUFF and 517 patients will be included in 2018 with CUFF for polyp detection Receives: Diagnostic Test: cuff assisted colonoscopy(with cuff use of endocuff vision second generation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
detection of polyp or adenoma with cuff
Measured: during procedure
Secondary outcomes (5)
POLYP DETECTION RATE
Measured: during procedure
morbidity : perforation rate
Measured: 21 DAYS AFTER PROCEDURE
CAECAL INTUBATION RATE
Measured: DURING PROCEDURE
TIME TO REACH CAECUM
SEC
Measured: DURING PROCEDURE
WITHDRAWAL TIME
SEC
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 posted29 Nov 2018
- Study start25 Oct 2018
- Primary completion26 Sep 2019
- Study completion26 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic PolypStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,034 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinique du Trocadéro
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03758872
- Sponsor's protocol ID
- 2018-A01397-48
- Acronym
- CUFF-TROCADERO
- Status last verified
- Oct 2018
- First submitted
- 26 Oct 2018
- Last updated
- 29 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- USE OF ENDOCUFF SECOND GENERATION IN THE COLIC POLYPS DETECTION: HISTORIC COHORTE PROSPECTIVE COMPARATIVE
- ClinicalTrials.gov ID
- NCT03758872
- Acronym / sponsor ID
- CUFF-TROCADERO / 2018-A01397-48
- Conditions
- Colonic Polyp, Colonoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,034 participants (actual)
- Lead sponsor
- Clinique du TrocadéroUniversity, hospital or other
- Study start
- 25 Oct 2018 (actual)
- Primary completion
- 26 Sep 2019 (actual)
- Study completion
- 26 Sep 2019 (actual)
- First posted
- 29 Nov 2018 (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 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 in routine colonoscopy.
This is a prospective comparative cohort, on 1034 patients, 517 patients with ECV in prospective group and 517 without ECV in retrospective group
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| historical comparaison whithout cuff | – | Diagnostic Test: cuff assisted colonoscopy(with cuff use of endocuff vision second generation)517 patients included in 2017 without CUFF and 517 patients will be included in 2018 with CUFF for polyp detection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient of all participating physicians for total colonoscopic exploration over the study periods
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 |
|---|---|---|
| cuff assisted colonoscopy(with cuff use of endocuff vision second generation)Also: colonoscopy with polypectomy or mucosectomy, standard colonoscopy ( without use of endocuff vision)this is a cohort prospective comparative, a group without cuff in 2017, 517 patient included in the retrospective phase, and in 2018, 517 patient will be included in the prospective phase with CUFF for detecting polyps | Diagnostic test | historical comparaison whithout cuff |
Primary outcome
detection of polyp or adenoma with cuff
Time frame: during procedure
5 secondary outcomes
POLYP DETECTION RATE
Time frame: during procedure
morbidity : perforation rate
Time frame: 21 DAYS AFTER PROCEDURE
CAECAL INTUBATION RATE
Time frame: DURING PROCEDURE
TIME TO REACH CAECUM
Time frame: DURING PROCEDURE
WITHDRAWAL TIME
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 2021.
- 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.
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?
An observational study of Colonic Polyp and Colonoscopy, run by Clinique du Trocadéro 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 2021. 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?
detection of polyp or adenoma with cuff (time frame: during procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2021.