Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02946021 | Response to Intermittent Pneumatic Compression Therapy in Head and Neck Cancer-Related Lymphedema | PHASE1 | COMPLETED | 11 | — | — | Oct 1, 2016 | Feb 1, 2018 | Apr 9, 2019 | 1 | United States |
Demonstrate the ability of the Flexitouch system to move lymph/enhance lymphatic uptake (indicated by increased functionality of vessels and/or changes in area of dermal backflow) as measured by Indocyanine Green (ICG) lymphography.
| Arm | Type | Description |
|---|---|---|
| Pneumatic Compression-1 session per day | EXPERIMENTAL | Head and neck garments for pneumatic compression device for treatment of lymphedema (1 session per day) with imaging using NIRFLI with ICG (Indocyanine green). |
| Pneumatic Compression-2 sessions per day | EXPERIMENTAL | Head and neck garments for pneumatic compression device for treatment of lymphedema (2 sessions per day) with imaging using NIRFLI with ICG (Indocyanine green). |
| Name | Type | Description |
|---|---|---|
| Head and neck garments for pneumatic compression device | DEVICE | Pneumatic compression device cleared for use by patients who are under medical supervision for the treatment of 1) lymphedema (primary or secondary); 2) edema resulting from mastectomies, trauma, sports injuries or post immobilization; 3) venous insufficiencies; 4) wounds; and 5) stasis dermatitis, venous stasis ulcers, arterial leg ulcers and diabetic foot ulcers and treatment of head and neck lymphedema |
| NIRFLI with ICG | DRUG | Near-infrared Fluorescence Lymphatic Imaging following the off-label use of Indocyanine Green as a lymph contrast agent and the use of a custom designed fluorescence imager to dynamically follow lymphatic movement in subjects. |
Inclusion Criteria: * Participants must be 18 years of age or older * Participants must be diagnosed with Lymphedema of the Head and/or Neck * Participants must be diagnosed with squamous cell carcinoma of the oral cavity, oropharynx or larynx and underwent surgery and radiation as part of their st...