Status:
UNKNOWN
Efficiency Clinical Study of NOVATEX MEDICAL Compression Garments in Patients With Ehlers-Danlos Syndrome
Lead Sponsor:
Novatex Medical
Collaborating Sponsors:
EVAMED
Conditions:
Ehlers-Danlos Syndrome
Eligibility:
All Genders
15-60 years
Phase:
NA
Brief Summary
Objective of this study is to assess the efficiency of NOVATEX MEDICAL compression garments in patients with an Ehlers-Danlos syndrome (EDS). To answer this objectif a comparison before/after use of ...
Detailed Description
Inclusion period: 1 year Follow-up period: 26 months Study period : 38 months Patient visits will be organized as follow: * V0: first visit at inclusion, clinical evaluation * V1: 4 months after inc...
Eligibility Criteria
Inclusion
- Patient between 15 and 60 years old
- Ehlers-Danlos Syndrome type: " classical ", " classical-like ", " hypermobile ", " arthrochalasia ", " kyphoscoliotic ", " musculocontractural " ou " myopathic ", as defined in the new international EDS classification 2017
- Patient who have never used compression garments
- Patient for whom compression garments will be prescribed at 4 months
- Patient who have dated and signed a consent form
- Patient who have understood the study
- Patient who are affiliated to French social health insurance system and/or in compliance with the recommendations of the national law in force relating to biomedical research
Exclusion
- patient under guardianship or enabled to complete questionnaires
- pregnant or breastfeeding woman
- patient who presents allergy to one of compression garments components
- patient with a current medical history who promotes postural disorders
- patient with an asymptomatic "Hypermobile Sprectrum Disorder" type of EDS as defined in the new international EDS classification 2017
- patient with a current or recent (\<3months) participation in another investigational study
Key Trial Info
Start Date :
December 21 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2023
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT03330977
Start Date
December 21 2017
End Date
March 31 2023
Last Update
March 23 2021
Active Locations (10)
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1
Centre Médical ISM
Boulogne-Billancourt, France, 92100
2
CHU de CAEN
Caen, France, 14033
3
Hopital Saint Joseph
Marseille, France, 13285
4
Chu de Marseille - Hôpital de La Conception
Marseille, France, 13385