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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02253186
Other study ID # 2014-A01008-39
Secondary ID
Status Completed
Phase N/A
First received September 24, 2014
Last updated December 4, 2015
Start date September 2014
Est. completion date June 2015

Study information

Verified date December 2015
Source Thuasne
Contact n/a
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Interventional

Clinical Trial Summary

The objective of the study is to assess the effect of a new Armsleeve, worn during the night during maintenance phase of upper limb lymphoedema treatment in combination with Day-time usual lymphology hosiery.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date June 2015
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Unilateral secondary upper limb lymphoedema of stage II or III, following breast cancer

- Patients hospitalized for an intensive phase of decongestive lymphoedema therapy (DLT) for whom a decrease of lymphoedema volume has been achieved during hospitalization

- Lymphoedema with evident pitting sign (assessed as ++ or +++)

- Requiring compression therapy for, at least, the next 3 months.

- Affected arm that fits with one of the 6 standard sizes of the Auto-Adjustable MOBIDERM® armsleeve provided.

- Signed informed consent prior to any study-mandated procedure.

- Not under any administrative or legal supervision.

- Covered by a health insurance system

Exclusion Criteria:

- Stage I lymphoedema

- Active cellulitis

- Lymphoedema associated with active cancer needing acute chemotherapy

- Motor and sensitive neurological deficiency

- Post-operative oedema (i.e acute oedema following breast cancer-related surgery)

- Patient participating in any other clinical study

- Unlikely to be followed up to 3 months with clinical assessment

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Auto-Adjustable MOBIDERM Armsleeve


Locations

Country Name City State
France CHU Montpellier - Hôpital St Eloi - Service Maladies Vasculaires Montpellier Cedex 5

Sponsors (1)

Lead Sponsor Collaborator
Thuasne

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in excess arm volume Excess arm volume is defined as the volumetric difference between the affected upper limb compared to the contralateral upper limb, calculated with truncated cone formula between Day 0 and Day 30 No
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