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NIRFLI with ICG · 1 trial · 3 indications
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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Bristol-Myers Squibb Company | BMY | 5 | PHASE3 | ACE-536 |
| AbbVie, Inc. | ABBV | 4 | PHASE3 | Navitoclax, Ruxolitinib |
| Novartis AG Sponsored ADR | NVS | 3 | PHASE3 | Pelabresib, Ruxolitinib |
| Karyopharm Therapeutics, Inc. | KPTI | 4 | PHASE3 | Selinexor, Ruxolitinib |
| Geron Corporation | GERN | 2 | PHASE3 | Imetelstat |
| Merck & Co., Inc. | MRK | 1 | PHASE3 | Bomedemstat |
| Incyte Corporation | INCY | 10 | PHASE2 | Ruxolitinib |
| GSK plc Sponsored ADR | GSK | 2 | PHASE2 | MMB |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 1 | PHASE2 | Elritercept, Ruxolitinib |
| Eli Lilly and Company | LLY | 1 | PHASE1 | LY3410738, Venetoclax, Azacitidine |
| Disc Medicine, Inc. | IRON | 1 | PHASE1 | DISC-0974 |
| Galecto, Inc. | GLTO | 1 | PHASE2 | GB2064 |
| Prelude Therapeutics, Inc. | PRLD | 1 | PHASE1 | PRT12396 |
| United Therapeutics Corporation | UTHR | 1 | PHASE2 | bomedemstat |
NIRFLI with ICG is used for head and neck neoplasms, specifically in the context of head and neck cancer-related lymphedema. It is an investigational small molecule being studied in a Phase 1 clinical trial to evaluate the response to intermittent pneumatic compression therapy in patients with this condition.
NIRFLI with ICG is developed by Tactile Systems Technology, Inc., a company traded under the ticker symbol TCMD. The company is conducting clinical research on this investigational therapy for head and neck cancer-related lymphedema.
NIRFLI with ICG is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and efficacy in patients with head and neck neoplasms.
NIRFLI with ICG is associated with one completed clinical trial, NCT02946021, titled "Response to Intermittent Pneumatic Compression Therapy in Head and Neck Cancer-Related Lymphedema." This Phase 1 study enrolled 11 participants in the United States and was not randomized or double-blinded.
NIRFLI with ICG is a specific investigational therapy developed by Tactile Systems Technology, Inc. No alternative names for this drug have been disclosed in the available clinical trial information. It is being studied for its potential role in managing head and neck cancer-related lymphedema.