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Clinical Trials/NCT06589882
NCT06589882Not yet recruitingNot Applicable

French Prospective Cohort of Innovative Endoscopic Interventions in Expert Centers

Centre Hospitalier Universitaire de Nīmes2 sites in 1 country10,000 target enrollmentStarted: October 1, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
10,000
Locations
2
Primary Endpoint
Evaluate the effectiveness of diagnostic, therapeutic and/or innovative endoscopic practiced in French expert centers over the next 10 years.

Study Overview

Brief 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.

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

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

  • Evaluate the safety of diagnostic and therapeutic and/or innovative endoscopic techniques performed in French expert centers over the next 10 years.(10 years)
  • Evaluate the secondary failure rate(10 years)
  • Evaluate operating time(10 years)
  • Evaluate inter-operator variability in efficacy(10 years)
  • Evaluate long-term efficacy(10 years)

Investigators

Sponsor
Centre Hospitalier Universitaire de Nīmes
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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