CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 236 enrolled
Drug / intervention
Advanced Pneumatic Compression Device (APCD) +1 moredevice
Likely dose
Flexitouch Plus once dailyAI-extracted
Key inclusion· 5
  • Age 18 years or older
  • Pathologically confirmed head and neck cancer (larynx, pharynx, oral cavity, paranasal sinuses, major salivary glands, or unknown primary)
  • Completed curative-intent cancer therapy with no evidence of active cancer at enrollment
  • Diagnosis of internal or external head and neck lymphedema
Key exclusion· 6
  • Previous treatment with advanced pneumatic compression device or usual care for head and neck lymphedema
  • Acute facial infection (facial or parotid gland abscess)
  • Known carotid sinus hypersensitivity syndrome
  • Symptomatic carotid artery disease: recent TIA, ischemic stroke, or amaurosis fugax within 30 days

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04797390
NCT04797390N/ACompleted

A Randomized Trial of an Advanced Pneumatic Compression Device vs. Usual Care for Head and Neck Lymphedema

Tactile Medical·interventional·Posted Mar 15, 2021·Updated Mar 2, 2026

In Brief

A clinical study evaluating Advanced Pneumatic Compression Device (APCD) and Usual Care for Lymphedema and 4 related conditions. Completed, enrolled 236 participants across 10 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20222023202420252026
First PostedMar 15, 2021
Enrollment StartSep 23, 2021
Primary CompletionDec 3, 2024
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 5.3 years ago

Interventions

Advanced Pneumatic Compression Device (APCD)device

Once daily treatment with Flexitouch Plus.

Usual Careother

Usual care consists of a two-phase CDT. Phase 1 includes consultation with a lymphedema therapist, patient education, MLD, compression garments or bandages, skin care techniques, and a program of exercises and postural recommendations. Phase 2 consists of ongoing self-care, where patients conduct a life-long program of disease management that mimics the program in phase 1.