Status:
UNKNOWN
Development of a Specific Scale of Life'Quality for Children With Low-flow Vascular Malformations
Lead Sponsor:
University Hospital, Toulouse
Conditions:
Vascular Malformations
Eligibility:
All Genders
11-15 years
Phase:
NA
Brief Summary
The low-flow malformations include venous and lymphatic malformations. The malformation often affects the skin and can extend deep to the muscles and bone, as well as to deep organs. Children with low...
Detailed Description
The low-flow vascular malformations include venous and lymphatic malformations. These malformations are made of dilated dysplastic vessels in which the circulation is lowed down, which can lead to phe...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Phase 1:
- Patient with slow-flow vascular malformation, regardless of clinical form, severity (clinical and imaging diagnosis), aged 11 to 15 years-old.
- Patient with slow-flow vascular malformation, whatever its clinical form, its severity (clinical and imaging diagnosis), aged over 15 years-old.
- Parents of a patient with slow-flow vascular malformation, regardless of clinical form, severity (clinical and imaging diagnosis), aged 11 to 15 years-old inclusive
- Patient affiliated to a social security scheme
- Patient having given his consent or for the minor whose legal representative has given written informed consent.
- Phase 2 :
- Patient with slow-flow vascular malformation, regardless of clinical form, severity (clinical and imaging diagnosis), 11 to 15 years-old of age included.
- Patient affiliated to a social security scheme
- Patient having given his consent or for the minor whose legal representative has given his informed consent
- Exclusion criteria :
- For both phases: Pregnant or lactating women or girls,
- Vulnerable persons,
- Majors subject to a legal protection measure or unable to express their consent Phase 1: Patient or parent who does not speak the French language and therefore are unable to express themselves in the focus groups.
- Patient under 11 years-old; Phase 2 : Patient who does not speak French and is therefore unable to complete quality of life questionnaires
- Patient under 11 or over 15 years-old.
Exclusion
Key Trial Info
Start Date :
February 23 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2019
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT03440827
Start Date
February 23 2018
End Date
February 1 2019
Last Update
March 5 2018
Active Locations (3)
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1
UHBordeaux
Bordeaux, France, 33076
2
UHChambray
Chambray-lès-Tours, France, 37170
3
UHNantes
Nantes, France, 44093