NCT06589882

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
102mo left

Started Oct 2024

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress16%
Oct 2024Sep 2034

First Submitted

Initial submission to the registry

September 6, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
12 days until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2034

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2034

Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

9.9 years

First QC Date

September 6, 2024

Last Update Submit

September 6, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

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

    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.

    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

Interventions

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Chu Nimes

Nîmes, 30900, France

Location

Hôpital Européen Georges Pompidou AP-HP

Paris, 75015, France

Location

Central Study Contacts

Ludovic Caillo, MD

CONTACT

Anissa MEGZARI

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2024

First Posted

September 19, 2024

Study Start

October 1, 2024

Primary Completion (Estimated)

September 1, 2034

Study Completion (Estimated)

September 1, 2034

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations