EndoscopyCoPPInENCT06589882
French Prospective Cohort of Innovative Endoscopic Interventions in Expert Centers
An observational study of Endoscopy and Innovative Procedures, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
Trial summary
The creation of a multi-center French cohort pooling data from innovative endoscopies carried out in France every year would make it possible to produce excellent scientific results and analyze on a large scale the results of our current practices. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endoscopy, Innovative Procedures
- What is being tested?
- Effectiveness of diagnostic and therapeutic and/or innovative endoscopic techniques
- How many people
- 10,000 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Oct 2024to 1 Sep 2034
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: All patients undergoing innovative diagnostic or therapeutic endoscopy who do not express opposition to the use of their data from examination reports. The aim of the cohort is to provide follow-up data on innovative procedures in digestive endoscopy, in order to justify their value. Patients included in the CoPPInE innovative digestive endoscopy cohort will be considered as undergoing innovative endoscopy
Who may be able to join
- Patients \> 18 yo
- Patient able to give consent
- Patient with innovative endoscopy
Who cannot join
- Opposition to participation in the present project to be notified in the file
- Patient under court protection
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites
Chu Nimes
Nîmes, 30900
Ludovic CAILLO, Dr, 0466683794, ludovic.caillo@chu-nimes.fr
Hôpital Européen Georges Pompidou AP-HP
Paris, 75015
ENRIQUE PEREZ-CUADRADO ROBLES, Dr, 0156095700, enrique.perez@aphp.fr
About this study
The creation of a multi-center French cohort pooling data from innovative endoscopies carried out in France every year would make it possible to produce excellent scientific results and analyze on a large scale the results of our current practices.
Read the detailed description
Diagnostic and therapeutic digestive endoscopy has been booming over the last 10 years. Many new techniques in digestive tract or hepato-bilio-pancreatic endoscopy are introduced every year. France is the Western country with the most technical skills in terms of the number of experts relative to the size of its territory, but is lagging far behind in terms of the promotion and reimbursement of these techniques by health insurance funds. France is also experiencing difficulties in centralizing health data from the thousands of endoscopies performed in the country every year. Pooling this data across the country, following the example of certain European and international partners (the Dutch, English and Australians), would make it easier to exploit data from innovative, sometimes rare or confidential digestive endoscopy procedures, and to justify their reimbursement once their usefulness has been confirmed through large-scale descriptive prospective studies associated with national multicenter publications.
The creation of a multi-center French cohort pooling data from innovative endoscopies carried out in France every year would make it possible to produce excellent scientific results and analyze on a large scale the results of our current practi
- Conditions
- Endoscopy, Innovative Procedures
- Being tested
- Effectiveness of diagnostic and therapeutic and/or innovative endoscopic techniques
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effectiveness of diagnostic and therapeutic and/or innovative endoscopic techniquesOther
Evaluate the effectiveness of diagnostic and therapeutic and/or innovative endoscopic techniques practiced in French expert centers over the next 10 years with the rate of technical success (procedure completed) and clinical success (cure) of the digestive pathology presented by the patient who indicated endoscopy without recourse to a new intervention (endoscopic or surgical) within 30 days of the procedure.
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the effectiveness of diagnostic, therapeutic and/or innovative endoscopic practiced in French expert centers over the next 10 years.
Measured: 10 years
Secondary outcomes (5)
Evaluate the safety of diagnostic and therapeutic and/or innovative endoscopic techniques performed in French expert centers over the next 10 years.
Measured: 10 years
Evaluate the secondary failure rate
Measured: 10 years
Evaluate operating time
Measured: 10 years
Evaluate inter-operator variability in efficacy
Measured: 10 years
Evaluate long-term efficacy
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Oct 2024 (estimated)
- Primary completion1 Sep 2034 (estimated)
- Study completion1 Sep 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndoscopyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- 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
- 10,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06589882
- Sponsor's protocol ID
- LOCAL/2024/LC-01
- Acronym
- CoPPInE
- Status last verified
- Sep 2024
- First submitted
- 6 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- French Prospective Cohort of Innovative Endoscopic Interventions in Expert Centers
- ClinicalTrials.gov ID
- NCT06589882
- Acronym / sponsor ID
- CoPPInE / LOCAL/2024/LC-01
- Conditions
- Endoscopy, Innovative Procedures
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 1 Sep 2034 (estimated)
- Study completion
- 1 Sep 2034 (estimated)
- First posted
- 19 Sep 2024 (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 creation of a multi-center French cohort pooling data from innovative endoscopies carried out in France every year would make it possible to produce excellent scientific results and analyze on a large scale the results of our current practices.
Detailed description
Diagnostic and therapeutic digestive endoscopy has been booming over the last 10 years. Many new techniques in digestive tract or hepato-bilio-pancreatic endoscopy are introduced every year. France is the Western country with the most technical skills in terms of the number of experts relative to the size of its territory, but is lagging far behind in terms of the promotion and reimbursement of these techniques by health insurance funds. France is also experiencing difficulties in centralizing health data from the thousands of endoscopies performed in the country every year. Pooling this data across the country, following the example of certain European and international partners (the Dutch, English and Australians), would make it easier to exploit data from innovative, sometimes rare or confidential digestive endoscopy procedures, and to justify their reimbursement once their usefulness has been confirmed through large-scale descriptive prospective studies associated with national multicenter publications.
The creation of a multi-center French cohort pooling data from innovative endoscopies carried out in France every year would make it possible to produce excellent scientific results and analyze on a large scale the results of our current practi
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing innovative diagnostic or therapeutic endoscopy who do not express opposition to the use of their data from examination reports. The aim of the cohort is to provide follow-up data on innovative procedures in digestive endoscopy, in order to justify their value. Patients included in the CoPPInE innovative digestive endoscopy cohort will be considered as undergoing innovative endoscopy
Key inclusion criteria (3 listed)
- Patients \> 18 yo
- Patient able to give consent
- Patient with innovative endoscopy
Key exclusion criteria (2 listed)
- Opposition to participation in the present project to be notified in the file
- Patient under court protection
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 |
|---|---|---|
| Effectiveness of diagnostic and therapeutic and/or innovative endoscopic techniquesEvaluate the effectiveness of diagnostic and therapeutic and/or innovative endoscopic techniques practiced in French expert centers over the next 10 years with the rate of technical success (procedure completed) and clinical success (cure) of the digestive pathology presented by the patient who indicated endoscopy without recourse to a new intervention (endoscopic or surgical) within 30 days of the procedure. | Other | – |
Primary outcome
Evaluate the effectiveness of diagnostic, therapeutic and/or innovative endoscopic practiced in French expert centers over the next 10 years.
Time frame: 10 years
5 secondary outcomes
Evaluate the safety of diagnostic and therapeutic and/or innovative endoscopic techniques performed in French expert centers over the next 10 years.
Time frame: 10 years
Evaluate the secondary failure rate
Time frame: 10 years
Evaluate operating time
Time frame: 10 years
Evaluate inter-operator variability in efficacy
Time frame: 10 years
Evaluate long-term efficacy
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endoscopy and Innovative Procedures, run by Centre Hospitalier Universitaire de Nīmes 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 3 inclusion and 2 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: opening soon, as of the sponsor's last update on 19 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ludovic Caillo, MD (0466683794, ludovic.caillo@chu-nimes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the effectiveness of diagnostic, therapeutic and/or innovative endoscopic practiced in French expert centers over the next 10 years. (time frame: 10 years). 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 19 Sep 2024.