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NCT04797390 · ClinicalTrials.gov registry record · NA
A Study Evaluating an Advanced Pneumatic Compression Device Versus Usual Care for Treatment of Head and Neck Lymphedema
A NA study of Lymphedema and Lymphedema, Secondary, sponsored by Tactile Medical.
- Completed
- Registry status
- NA
- Development phase
- 236
- Enrollment target
- 10
- Study locations
NCT04797390: Completed NA study of Lymphedema and Lymphedema, Secondary, sponsored by Tactile Medical.
NCT04797390 is a NA study of Lymphedema and Lymphedema, Secondary that has completed, run by Tactile Medical. The registered enrollment target is 236 participants, below the 9,293-participant average among 34 other Lymphedema trials with a reported enrollment target (97% lower). The trial reports 10 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04797390, a NA study of Lymphedema and Lymphedema, Secondary, has completed, sponsored by Tactile Medical.
- COMPLETED
- Registry status
- NA
- Development phase
- 236 participants
- Enrollment target
- 10
- Study locations
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.
Primary Outcome
The change in average site score from baseline assessed via endoscopy using the Modified Patterson Scale. The range for each site was 0-3: Normal, Mild, Moderate, Severe. A lower score means a better outcome.
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 |
What the finished NCT04797390 record still lists
NCT04797390 is an interventional study that assigns participants to a tested intervention. The registered 236 participants enrollment target is mid-sized for trials with a published cap, below the 9,293-participant average among 34 other Lymphedema trials with a reported enrollment target (97% lower).
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.
NCT04797390 lists 10 locations in 8 states (Michigan, New York, Alabama).
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.
What interventions are being tested in trial NCT04797390?
The interventions under investigation include: Usual Care (OTHER), Advanced Pneumatic Compression Device (APCD) (DEVICE).
Who is sponsoring clinical trial NCT04797390?
This trial is sponsored by Tactile Medical, which has 14 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Lymphedema
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04797390's enrollment target sits among peer trials
236 12th of 34 higher than 23 of 34 other Lymphedema trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lymphedema trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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