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French Observational Study With Colic Capsule

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ClinicalTrials.gov Identifier: NCT03533894
Recruitment Status : Completed
First Posted : May 23, 2018
Last Update Posted : May 23, 2018
Sponsor:
Information provided by (Responsible Party):
Jean Christophe Saurin, Hôpital Edouard Herriot

Study Description
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Brief Summary:
colic capsule usings with patients without possible colic endoscopy

Condition or disease Intervention/treatment
Colic Capsule Interest Device: colic capsule

Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 680 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: French Observational Study With Colic Capsule
Actual Study Start Date : January 1, 2011
Actual Primary Completion Date : June 30, 2016
Actual Study Completion Date : May 1, 2018
Groups and Cohorts
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Intervention Details:
  • Device: colic capsule
    colic polyp diagnosis

Outcome Measures
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Primary Outcome Measures :
  1. number of polyps or lesions [ Time Frame: 5 years ]
    number of polyps or lesions


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
men or women with colic endoscopy problems
Criteria

Inclusion Criteria:

  • anesthesia not possible
  • incomplete colic endoscopy
  • colic endoscopy refused

Exclusion Criteria:

  • none
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

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Responsible Party: Jean Christophe Saurin, Professor, Hôpital Edouard Herriot
ClinicalTrials.gov Identifier: NCT03533894    
Other Study ID Numbers: ONECC
First Posted: May 23, 2018    Key Record Dates
Last Update Posted: May 23, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colic
Infant, Newborn, Diseases