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A Study Evaluating an Advanced Pneumatic Compression Device Versus Usual Care for Treatment of Head and Neck Lymphedema
NCT04797390 · View on ClinicalTrials.gov ↗
Study Summary
To compare the effectiveness of an APCD to Usual Care in the management of lymphedema and fibrosis (LEF) in head and neck cancer (HNC) survivors.
Conditions Studied
Interventions
- OTHER Usual Care
- DEVICE Advanced Pneumatic Compression Device (APCD)
Study Locations (10)
Michigan
- University of Michigan — Ann Arbor
- Karmanos Cancer Institute — Detroit
New York
- Richmond University Medical Center — Staten Island
- Montefiore Medical Center — The Bronx
Alabama
- University of Alabama — Birmingham
Illinois
- Rush University Medical Center — Chicago
Kentucky
- University of Louisville — Louisville
Maryland
- Johns Hopkins University — Baltimore
Tennessee
- Vanderbilt University Medical Center — Nashville
Texas
- Advanced Head & Neck Rehabilitation Center of Texas — Fort Worth
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 236 participants |
| Start Date | 2021-09-23 |
| Est. Completion | 2024-12-03 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04797390
The ClinicalTrials.gov registry entry for NCT04797390 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 236 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tactile Medical, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 5 conditions, with Lymphedema appearing as the primary indexed condition, and to 2 interventions — of which Usual Care is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04797390 reports 10 study locations spanning 8 distinct geographic areas — top geographies include Michigan, New York, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04797390 about?
NCT04797390 is a clinical study titled "A Study Evaluating an Advanced Pneumatic Compression Device Versus Usual Care for Treatment of Head and Neck Lymphedema". To compare the effectiveness of an APCD to Usual Care in the management of lymphedema and fibrosis (LEF) in head and neck cancer (HNC) survivors.
What is the current status of trial NCT04797390?
This trial is currently completed. It is a NA study. The enrollment target is 236 participants. The study started on 2021-09-23. Estimated completion is 2024-12-03.
What conditions does trial NCT04797390 study?
This clinical trial studies the following conditions: Lymphedema, Lymphedema, Secondary, Lymphedema of Face, Lymphedema Due to Radiation, Lymphedema; Surgical. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04797390?
The interventions under investigation include: Usual Care (OTHER), Advanced Pneumatic Compression Device (APCD) (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04797390?
This trial is sponsored by Tactile Medical, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04797390 being conducted?
This trial has 10 study locations across Alabama, Illinois, Kentucky, Maryland, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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