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NCT06580743 · ClinicalTrials.gov registry record
Efficacy Verification in Early Diagnosis and Management of Lymphedema Through Home Body Water Analyzer
A clinical trial, sponsored by University of Minnesota.
- Completed
- Registry status
- 52
- Enrollment target
NCT06580743: Completed study, sponsored by University of Minnesota.
NCT06580743 is a clinical trial that has completed, run by University of Minnesota. The registered enrollment target is 52 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06580743 has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- 52 participants
- Enrollment target
Study Summary
Breast cancer is the second most common cancer in women. One in five women who have been treated for breast cancer develop lymphedema. Lymphedema is a very common result of breast cancer and its treatment. Lymphedema is the build-up of fluid in tissues, which results in tissue swelling. The lymph system is a network of lymph vessels, tissues, and organs that carry extra fluid from your cells/tissues throughout the body. If this lymph fluid is not able to flow in the body how it should, there will be swelling which can lead to lymphedema. It can be classified into stages 0 to 3 depending on the severity of the condition. Stages 0 and 1 are reversible, and through early diagnosis and treatment, the recovery to the normal volume and normal skin status of arms can be possible. On the other hand, stage 2 or higher is irreversible, and tissue fibrosis progresses and cannot return to normal skin; therefore, it is important to detect early and start treatment. This is an observational longitudinal study. Potential participants will be recruited for follow-up after breast cancer surgery. Only patients who fit the inclusion criteria will be considered for participation in the study and contacted by the healthcare provider. Standard of care will be used to guide any treatment needed by participants while they are part of the study.
Primary Outcome
Measurement of impedances and extracellular water (ECW) ratio between affected and unaffected sides at initial visit using the clinical and home units (InBody 770 and InBody BWA ON). Inbody BWA 770 Timeline: baseline, 3, 6, 9, 12 month Inbody BWA ON Timeline: 2x/day x 12 months
Interventions
- OTHER No intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2024-06-12 |
| Est. Completion | 2025-09-30 |
What the finished NCT06580743 record still lists
NCT06580743 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 52 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which No intervention is the first listed.
NCT06580743 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06580743 about?
NCT06580743 is a clinical study titled "Efficacy Verification in Early Diagnosis and Management of Lymphedema Through Home Body Water Analyzer". Breast cancer is the second most common cancer in women. One in five women who have been treated for breast cancer develop lymphedema. Lymphedema is a very common result of breast cancer and its treatment. Lymphedema is the build-up of fluid in tissues, which results in tissue swelling. The lymph sy...
What is the current status of trial NCT06580743?
This trial is currently completed. The enrollment target is 52 participants. The study started on 2024-06-12. Estimated completion is 2025-09-30.
What interventions are being tested in trial NCT06580743?
The interventions under investigation include: No intervention (OTHER).
Who is sponsoring clinical trial NCT06580743?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
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