An Early Phase 1 interventional study of Advanced pneumatic compression device (APCD) and Advanced pneumatic compression device (APCD) with revised compression programming in Lower Extremity Lymphedema, sponsored by Tactile Medical. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-11.
Sponsored by Tactile Medical · Early Phase 1, Interventional, and Device feasibility
The goal of this pilot study is to learn if a revised method of compression improves lymphatic function compared to the current method of compression. The main questions:
529 studies on the registry are indexed under Lymphedema; 131 are open to participants now.
This study's planned enrollment of 5 is below the median of 50 across 369 interventional studies indexed under Lymphedema.
Browse Lymphedema studies →Tactile Medical is the lead sponsor of 15 studies on the registry; 1 is open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Advanced pneumatic compression device (APCD) · Device: Advanced pneumatic compression device (APCD) with revised compression programming · Drug: Indocyanine Green (IC-Green)
Single APCD treatment session at visit 1
APCD with revised compression programming will be single treatment session at visit 2
Indocyanine Green dye will be used to assess primary endpoint
Lymphatic anatomy
• The distance (cm) that lymph travels from injection sites
Time frame: Before and after 60-minute treatment in clinic with APCD
Lymphatic propulsion
• Number of lymph propulsion events per minute
Time frame: Before and after 60-minute treatment in clinic with APCD
Evaluate swelling in treatment limbs
• Changes in leg circumferential measurements (cm)
Time frame: Before and after 60-minute treatment in clinic with APCD
Evaluate swelling in treatment limbs
Change in local water content (ratio of % water content in legs to reference site)
Time frame: Before and after 60-minute treatment in clinic with APCD
Adverse Events
• Adverse Event assessments
Time frame: Through completion of study at Visit 2, up to 4 weeks
Plan to share: No — This is a pilot study.
No publications or documents are linked to this record.
Started Jul 2026 (actual). Primary completion is estimated for Sep 2026, 2 months after the start.
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