Polyps of ColonNCT03448653
Contribution of Narrow Band Imaging (NBI) for the Characterization of Scalloped Polyps (NBI POLYPES COLIQUES)
A study testing Colonoscopy with NBI in people with Polyps of Colon, run by Centre Hospitalier Departemental Vendee at 2 sites in France.
Trial summary
This prospective bicentric trial aims to evaluate the diagnostic performance of the characterization of scalloped polyps less than 20 millimeter in NBI (Narrow Band Imaging) in patients with screening colonoscopy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polyps of Colon
- What is being tested?
- Colonoscopy with NBI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 314 participants
- Where
- 2 sitesFrance
- Study dates
- 9 Jul 2018to 12 Jul 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Patient with 1 or more polyps less than 20 mm observed during colonoscopy
Who cannot join
- Patient with an emergency colonoscopy for ongoing digestive bleeding or occlusion symptoms
- Patient with chronic inflammatory bowel disease (IBD): Crohn's disease or unclassified colitis
- Patient with familial adenomatous polyposis
- Pregnant or lactating woman
- Minor patient
- Major patient under tutorship, curatorship, or deprived of liberty
Show all 9Show fewer
- Patient unable to understand protocol and / or give express consent
- Patient not affiliated with a social security system or beneficiary of such a scheme
- Patient hospitalized or treated without their consent
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre Hospitalier Départemental Vendée
La Roche-sur-Yon, 85925
Centre Hospitalier Universitaire Nantes
Nantes, 44000
About this study
Official title: Contribution of Narrow Band Imaging (NBI) for the Characterization of Scalloped Polyps
This prospective bicentric trial aims to evaluate the diagnostic performance of the characterization of scalloped polyps less than 20 millimeter in NBI (Narrow Band Imaging) in patients with screening colonoscopy.
The NBI is a so-called "virtual" electronic staining technique available on conventional OLYMPUS endoscopes without additional intervention.
The colonoscopy procedure for each patient will not be different from a conventional colonoscopy examination with excision of all polyps visualized and anatomopathological analysis, except for a short time of analysis in NBI for each polyp detected before excision to classify the polyp in existing endoscopic classifications (ie NICE classification for adenomatous polyps and WASP classification for festooned polyps).
- Conditions
- Polyps of Colon
- Being tested
- Colonoscopy with NBI
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colonoscopy with NBIOther
Colonoscopy with NBI
| Study group | Role | What they receive |
|---|---|---|
| Colonoscopy with NBI | Experimental | Not described Receives: Other: Colonoscopy with NBI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of the NBI Compared to the Anatomopathological Analysis (= Reference Method)
Number of polyps characterized as scalloped (NICE II-) by NBI relative to the number of polyps characterized as scalloped in standard histology
Measured: An average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2018
- Study start9 Jul 2018
- Primary completion12 Jul 2022
- Study completion12 Jul 2022
Why it stopped: Slow recruitment, advances in technology
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Polyps of ColonStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 314 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Departemental Vendee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent MACE, Study director, Centre Hospitalier Départemental Vendée
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03448653
- Sponsor's protocol ID
- CHD010-17
- Status last verified
- Oct 2024
- First submitted
- 21 Feb 2018
- Last updated
- 29 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of Narrow Band Imaging (NBI) for the Characterization of Scalloped Polyps
- ClinicalTrials.gov ID
- NCT03448653
- Acronym / sponsor ID
- CHD010-17
- Conditions
- Polyps of Colon
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment, advances in technology
- Enrolment
- 314 participants (actual)
- Lead sponsor
- Centre Hospitalier Departemental VendeeUniversity, hospital or other
- Study start
- 9 Jul 2018 (actual)
- Primary completion
- 12 Jul 2022 (actual)
- Study completion
- 12 Jul 2022 (actual)
- First posted
- 28 Feb 2018 (actual)
- Results
- Posted 29 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective bicentric trial aims to evaluate the diagnostic performance of the characterization of scalloped polyps less than 20 millimeter in NBI (Narrow Band Imaging) in patients with screening colonoscopy.
The NBI is a so-called "virtual" electronic staining technique available on conventional OLYMPUS endoscopes without additional intervention.
The colonoscopy procedure for each patient will not be different from a conventional colonoscopy examination with excision of all polyps visualized and anatomopathological analysis, except for a short time of analysis in NBI for each polyp detected before excision to classify the polyp in existing endoscopic classifications (ie NICE classification for adenomatous polyps and WASP classification for festooned polyps).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colonoscopy with NBI | Experimental | Other: Colonoscopy with NBI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient with 1 or more polyps less than 20 mm observed during colonoscopy
Key exclusion criteria (9 listed)
- Patient with an emergency colonoscopy for ongoing digestive bleeding or occlusion symptoms
- Patient with chronic inflammatory bowel disease (IBD): Crohn's disease or unclassified colitis
- Patient with familial adenomatous polyposis
- Pregnant or lactating woman
- Minor patient
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 |
|---|---|---|
| Colonoscopy with NBIColonoscopy with NBI | Other | Colonoscopy with NBI |
Primary outcome
Sensitivity of the NBI Compared to the Anatomopathological Analysis (= Reference Method)
Time frame: An average of 1 month
Number of polyps characterized as scalloped (NICE II-) by NBI relative to the number of polyps characterized as scalloped in standard histology
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Vincent MACE study director
Centre Hospitalier Départemental Vendée
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colonoscopy with NBI in people with Polyps of Colon, run by Centre Hospitalier Departemental Vendee at 2 sites 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 1 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: stopped early, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 29 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Sensitivity of the NBI Compared to the Anatomopathological Analysis (= Reference Method) (time frame: An average of 1 month). 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 Nov 2024.