Status:
COMPLETED
The Equivalency of the Imp SFB7+ (L-Dex U400) With the Imp XCA Device
Lead Sponsor:
ImpediMed Limited
Conditions:
Lymphedema
Eligibility:
FEMALE
18-75 years
Brief Summary
The purpose of this project is to prove that the Imp™SFB7+ (L-Dex U400) is equivalent to the Imp™ XCA device in assessing Lymphoedema. The Imp™ XCA device is a simple device capable of assessing Lymph...
Detailed Description
When Lymphoedema is present, lymph and other fluids build up in the interstitial spaces of the tissues. This results in an overall increase in the total amount of extracellular fluid (ECF) in the limb...
Eligibility Criteria
Inclusion
- Groups 1 and 2
- Be female between the ages of 18-75 years.
- Self-describe general health as satisfactory.
- Understand the proposed study and be willing and fully able to comply with the study procedures.
- Be a willing participant and be capable of giving and has given informed written consent for entry into the study.
- Group 1
- Have been previously diagnosed, by current clinical practice, as having unilateral Lymphoedema of the arm of any severity.
- Have had a mastectomy or breast conservation surgery with axillary sampling or dissection, with or without adjuvant therapy.
Exclusion
- Have a known heart condition or an implantable device such as a pacemaker or ICD.
- Have a metallic surgical implant (e.g. total hip replacement) not including small implants such as sternal wires or surgical staples.
- Suffer from a renal disorder.
- Be taking diuretic medications.
- Have consumed large amounts of alcohol or caffeinated beverages within six hours of the study.
- Have undertaken excessive exercise within two hours of BIA.
- Have a reported fever of \> 38oC at time of screening.
- Be currently in the fourth week of the menstrual cycle.
- Be pregnant or currently breastfeeding.
- Be a relative of any member of study staff or is an employee or a relative of an employee of ImpediMed Ltd.
Key Trial Info
Start Date :
November 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00766935
Start Date
November 1 2007
End Date
April 1 2008
Last Update
August 27 2021
Active Locations (1)
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1
Queensland Lymphoedema and Breast Oncology Physiotherapy
Brisbane, Queensland, Australia, 4032