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NCT Number: NCT06589882

French Prospective Cohort of Innovative Endoscopic Interventions in Expert Centers

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chu Nimes, Nîmes, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients > 18 yo
  • Patient able to give consent
  • Patient with innovative endoscopy

Exclusion criteria

  • Opposition to participation in the present project to be notified in the file
  • Patient under court protection

Treatment and study plan

Effectiveness of diagnostic and therapeutic and/or innovative endoscopic techniques

Other

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.

Primary outcomes

  1. Evaluate the effectiveness of diagnostic, therapeutic and/or innovative endoscopic practiced in French expert centers over the next 10 years.

    Time frame: 10 years

Secondary outcomes

  1. 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

  2. Evaluate the secondary failure rate

    Time frame: 10 years

  3. Evaluate operating time

    Time frame: 10 years

  4. Evaluate inter-operator variability in efficacy

    Time frame: 10 years

  5. Evaluate long-term efficacy

    Time frame: 10 years

Study contacts

Contact information is provided by the study sponsor or research team.

Anissa MEGZARI

CONTACT

[email protected]

0466683678

Ludovic Caillo, MD

CONTACT

[email protected]

0466683794

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Acronym: CoPPInE

Important dates

Study start
2024
Primary completion
2034
Study completion
2034
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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