Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2025-12-26 @ 1:18 PM
NCT ID:
NCT00757406
Eligibility Criteria:
Inclusion Criteria:
Group 1:
* Be 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.
* Have been previously diagnosed, by current clinical practice, as having unilateral Lymphoedema of the leg.
Group 2:
* Be 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.
Exclusion Criteria:
* 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 \> 38°C at time of screening.
* Be currently in the fourth week of the menstrual cycle.
* Be pregnant or currently breastfeeding.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00757406
Study Brief:
Protocol Section:
NCT00757406