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:
2025-12-24 @ 4:45 PM
Ignite Modification Date:
2025-12-24 @ 4:45 PM
NCT ID:
NCT06180850
Eligibility Criteria:
Inclusion Criteria:
* Participants with or without lipedema
* Age range = 18-80 years
* Participants with lipedema have a formal diagnosis by a physician using criteria in Appendix A of protocol
* Female
Exclusion Criteria: Volunteers in the lipedema or control group will be excluded with the following:
* Pregnant or breast-feeding
* Taking any anticoagulation or antiplatelet therapy other than aspirin (up to 100 mg daily)
* Active infection anywhere in the body, or open wound on the lower-extremities or at locations for ultrasound, bioimpedance, and tissue dielectric measurements
* Battery-operated device implanted that cannot be removed for ultrasound, DXA scan, bioimpedance, and tissue dielectric measurements
* Primary lymphedema
* Uncontrolled diabetes, renal disease, thyroid disease, or hypertension
* Hormone dysregulation or another significant clinical condition affecting hormone status as confirmed by clinical co-investigators
* Bone metastases
* Contrast imaging scan in the previous 7 days
* Nuclear medicine scan in previous 3 days
* Lumbar spine fusion
* Weigh more than 500 lb (226.8 kg)
Also excluded are subjects incapable of giving informed written consent:
* Subjects who have an inability to communicate with the researcher for any reason
* Subjects who are non-English speaking who cannot communicate through a translator, or if a translator is not available
* Subjects who cannot adhere to the experimental protocols for any reason
* Subjects who have limited mental ability to give informed consent due to mental disability, confusion, or psychiatric disorders
* Prisoners
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06180850
Study Brief:
Protocol Section:
NCT06180850