Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT06264817

Auto-Adjustable MOBIDERm Autofit Armsleeve in the Management of Upper Limb Lymphedema.

Led by Thuasne · Updated on 2024-09-23

40

Participants Needed

2

Research Sites

56 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study aims to assess Auto-Adjustable MOBIDERM® Autofit Armsleeve effect on upper limb volume excess compared to the compression bandages to manage the volume of upper limb lymphedema in patients with breast cancer related lymphedema

CONDITIONS

Official Title

Auto-Adjustable MOBIDERm Autofit Armsleeve in the Management of Upper Limb Lymphedema.

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Unilateral secondary upper limb lymphedema stage II or III after breast cancer
  • Volume difference between affected and healthy arm 10% or more
  • Affected arm fits one of the 6 standard sizes of the Auto-Adjustable MOBIDERM Autofit armsleeve
  • Signed informed consent before any study procedure
Not Eligible

You will not qualify if you...

  • Stage I lymphedema or lymphedema in multiple locations
  • Contraindication to compression therapy
  • Active cancer with need for acute chemotherapy, recurrence, or metastasis
  • Motor or sensory neurological deficits, psychiatric or addictive disorders
  • Pregnant or breastfeeding
  • Intolerance or known allergy to MOBIDERM Autofit components
  • Participation in another clinical study affecting study endpoints
  • Vulnerable adults under legal protection or unable to consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

ANKARA

Ankara, Turkey (Türkiye)

Actively Recruiting

2

Pinar BORMAN

Ankara, Turkey (Türkiye)

Actively Recruiting

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Research Team

B

Burcu DUYUR ÇAKIT, MD

CONTACT

A

ASTRID PICOLET

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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