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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02520843 |
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Date of registration:
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05/08/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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An Innovative Treatment for Fistula-in-ano in Crohn Disease : Local Micro Reinjection of Autologous Fat and SVF
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Scientific title:
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An Innovative Treatment for Fistula-in-ano in Crohn Disease : Local Micro Reinjection of Autologous Fat and Stromal Vascular Fraction |
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Date of first enrolment:
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October 2015 |
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Target sample size:
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10 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02520843 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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France
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Contacts
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Name:
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Jean-Charles GRIMAUD, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Assistance Publique Hopitaux De Marseille |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Disease of Crohn diagnosed for at least 6 months according to the recognized clinical,
endoscopic and histological criteria
- Presence of fistulas died anal complex estimated by clinical examination and MRI. A
fistula died anal complex is, by definition, a fistula which answers at least one of
the following criteria during its evolution: (1) high, trans-sphincter,
extra-sphincter or above sphincter Inter-sphincter. (2) Presence of = 2 external
openings. (3) Purulent Collections associated
- Active or slightly active Crohn luminal, defined by a CDAI (Crohn's Disease Activity
Index) = 220
Exclusion Criteria:
- Disease of Crohn activates mainly luminal with a CDAI = 220 requiring an immediate
treatment
- Patients having never received specific treatments of the anal died disease of Crohn
with fistula, including by antibiotics
- Presence of an abscess or collections of more than 2 cms unless this problem is solved
during the period of preparation
- Rectal and/or anal Stenosis and/or active proctitis, if it means a limitation of the
surgical procedure
- Patient having undergone an operation of the fistula other than the drainage
- Patients under corticoids or by having receiving in the previous four weeks
- Active Malignant Tumors or history of Malignant tumors
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Crohn Disease
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Intervention(s)
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Drug: stromal vascular fraction (SVF)
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Primary Outcome(s)
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efficacy (measured as an absence of purulent collections superior to 2 cms concerning the fistula measured clinically and by MRI)
[Time Frame: 48 weeks]
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safety (measured by an absence of fever and local inflammatories symptoms)
[Time Frame: 48 weeks]
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Secondary Outcome(s)
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improvement of quality of life (assessed by questionnaire)
[Time Frame: 48 weeks]
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Secondary ID(s)
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2013-002602-31
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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