French Prospective Cohort of Innovative Endoscopic Interventions in Expert Centers

Not yet recruiting

• Conditions: Endoscopy; Innovative Procedures

• Registration Number: NCT06589882
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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 Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-06
• Study First Submitted QC: 2024-09-06
• Last Update Submitted: 2024-09-06
• Study First Posted: 2024-09-10
• Last Update Posted: 2024-09-10
• Study Start: 2024-10-01
• Primary Completion: 2034-09-01
• Study Completion: 2034-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Chu Nimes; 🇫🇷 Nimes, France

Hôpital Européen Georges Pompidou AP-HP; 🇫🇷 Paris, France